Expert NetworkLife science experts from key parts of the pharmaceutical, biotech, and medical device industries craft original columns, exclusive to Life Science Connect audiences, on the most pressing issues. This seasoned group of key contributors who share their insights on Bioprocess Online, Cell & Gene, Clinical Leader, Med Device Online, Outsourced Pharma, and Pharmaceutical Online make up The Expert Network.

Experts expand topical coverage areas, imparting their expertise and hard-earned, first-hand best practices across life science product development and commercialization — from discovery, R&D, and clinical trials to outsourcing, regulatory, and market access. However, they do much more than simply create and share content. Experts engage directly with Life Science Connect readers, sharing ideas and exchanging opinions, serving as a critical link between readers and the industry at large. 

Below, you’ll find our current Expert Network contributors.


  • FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices

    On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.

  • What To Expect From A Remote Inspection -- & How To Navigate It

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

  • The 8-Step Checklist To Write Effective Investigation Reports

    It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

  • FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

  • How To Enhance “Operational Learning” In Biopharma

    According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.

  • 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals

    Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation. 

  • Data Integrity In Supply Chain Risk Management During Zero Trust

    Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.

  • The Role Of The Contract Manufacturer Under The EU MDR & IVDR

    As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.

  • Major Shift in Demand For Oxygen Therapy Devices – New Study For 2021

    Oxygen therapy is used to treat a variety of medical conditions, such as cancer, cystic fibrosis, and chronic obstructive pulmonary disease (COPD). The market is moving away from traditional cylinder-based methods of oxygen delivery toward what technology? And what type of device has emerged as an exemplary delivery system?

  • Harnessing The Power Of AI In MS Diagnosis, Monitoring, And Treatment

    A prime example of the future potential of artificial intelligence (AI) is in revolutionizing the way we diagnose, monitor, and treat multiple sclerosis (MS), thereby advancing our understanding of the disease course. To maximize the utility of AI in MS, drug developers and medtech manufacturers must strategically incorporate AI solutions into their approach to MS drug development and commercialization. 

  • Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare

    The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.

  • Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs

    The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 

  • Dental 3D Printing: Disruptive Trends In The Digital Dentistry Market For 2021

    Dental 3D printers have experienced a surge in popularity in recent years, reflecting the increasing range of applications and opportunity for revenue generation offered by these systems. How does this market look for 2021, and what is the one dental device disrupting the market?

  • Rating Risk Events: Why Adjusted Risk Likelihood (ARL) Should Replace Risk Priority Number (RPN)

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

  • Implementing EU MDR and IVDR: Lessons Learned, Part 2

    The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

  • AI/ML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval

    Application of artificial intelligence (AI) and machine learning (ML) in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. By digesting the different jurisdictional AI/ML regulatory frameworks that have been released (draft or enforceable), along with personal experience with the agencies, John Giantsidis, president of CyberActa, Inc., identifies the common denominators crucial to success.

  • Implementing EU MDR and IVDR: Lessons Learned, Part 1

    The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!

  • Establishing An Effective Calibration Program

    Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

  • Introduction to Injection Mold Verification

    Throughout Zachi Fizik's article series, he has focused on plastic parts used in your medical device and the associated mold production process. In this article, he explains the difference between T0 and T1, which is the first trial. He also discusses sending T1 remarks to the mold maker. With a combination of experience and agility, you'll be able to approve final samples in a timely manner.

  • Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III

    Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the interoperability, robustness, consumer protection, and patient safety requirements. Other countries will likely soon follow Germany's example.

  • Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management

    You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.

  • 7 Rules For Properly Interpreting Control Charts

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

  • Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part II

    Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance, and other countries will likely follow in its footsteps. In Part II of this three-part series, John Giantsidis of CyberActa, Inc. examines the data security requirements.

  • ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk

    This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in Dec. 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance. This article by Edwin L. Bills, member of ISO TC 210 JWG1, covers the change in the process for benefit-risk covered in Clause 8 of the standard.

  • Top 3 Trends Affecting The Dental Implants Market In 2021 And Beyond

    Dental implants have increasingly become the preferred treatment for edentulous individuals as practitioner expertise and supporting technology around dental implants continue to advance. William Guo and Kamran Zamanian, Ph.D., of iData Research Inc. delve into the three trends driving the growth of this market.

  • An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials

    An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.

  • Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part I

    Germany's BfArM (the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for digital health applications, and other countries will likely follow in its footsteps. John Giantsidis, president of CyberActa, Inc., gives an overview of the situation and will cover the many privacy requirements noted in the new guide in Part 1 of this three-part article series.

  • Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean?

    In the first two parts of this three-part series on ISO 14971 terminology, we discussed the terms “hazard” and “hazardous situation” in detail. In this third and final part, we will review the term “harm,” provide examples to illustrate how you can define potential harms applicable to your medical device, and explain how you can link them to relevant hazards and hazardous situations. 

  • With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices

    The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?

  • Closing The Loop On Risk Management With ISO 14971:2019

    Edwin L. Bills, member of ISO TC 210 JWG1, discusses the evolution of risk management standards for medical devices and how ISO 14971:2019's revision (which is also identical to EN ISO 14971:2019) is meant to "close the loop." Based on the extensive changes in Clause 10, all manufacturers of medical devices and in vitro medical devices will need extensive review and possible changes to their production and post-production activities section of their quality systems in order to meet the new requirements.

  • Avoiding ISO 14971 Mistakes — Are You Accurately Defining “Hazardous Situations”?

    There is a lot of confusion and inconsistency in the implementation of risk management systems to meet the requirements of ISO 14971. In the first part of this three-part series, we discussed the term “hazard” in detail. In this second part, we will review the term “hazardous situation” and provide examples to illustrate how you can define potential hazardous situations during risk analysis of your medical device.

  • 4 Steps To Kick Off Your Mold Production Project For Success

    Zachi Fizik of ZF Consulting has been involved with injection molds production since the early 1990s. In the first article in this two-part article series, he'll detail the four milestones that are relevant and necessary for all mold production projects, no matter how tight your budget is or how quickly your deadline looms.

  • Using Production And Postmarket Data To Validate FMEA Assumptions

    One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

  • Avoiding ISO 14971 Mistakes — Do You Really Understand The Term “Hazard”?

    Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a medical device. Yet, these terms are often misunderstood and misapplied. This first part of a three-part video series reviews the term “hazard” in detail, highlights areas of confusion, and illustrates a few examples to facilitate a better understanding and its application in risk analysis. 

  • Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues

    The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

  • Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending

    Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.

  • Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management

    The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based postmarket surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.

  • Tips For Building A Voluntary QA Culture In A 2021 COVID World

    As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

  • Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach

    Jayet Moon continues his four-part series on risk-based postmarket surveillance in the age of the EU Medical Device Regulations (MDR) with Part 2, which delves into the systems approach. Such an approach gives due consideration to process interfaces with other organizational functions and knowledge management. It would not only make compliance to EU MDR easy but also make the organizational processes much more effective and efficient.

  • Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation

    Jayet Moon begins this four-part series on risk-based postmarket surveillance (PMS) in the age of EU MDR by delving into the incident investigation. Such investigations are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. By looking into the Who? What? When? Where? Why? and How? of serious events related to your device, you'll be able to provide answers to regulatory bodies.

  • Fluid Management Equipment Market Poised For Growth In Europe

    In the gynecology market, as the use of hysteroscopes and other less invasive methods increases, more procedures will require the use of fluid management equipment. Notably, there has been significant growth in the sales of both capital equipment and tubing for fluid management during hysteroscopic procedures. This article discusses the current and future fluid management market in Europe.

  • Will Transcatheter Valves Continue Cannibalizing Surgical Aortic Valve Replacements?

    In 2019, the transcatheter aortic valve implantation (TAVI) device market garnered nearly 7 times that of the surgical aortic valve market. TAVI procedures are expected to account for an even larger share of aortic heart valve replacement procedures in Europe in 2021.

  • ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO 14971

    With ISO TR 24971:2020, the technical committee responsible for the medical device risk management standard has finally addressed the confusion around the policy for risk acceptability criteria and the difference between that and the criteria themselves.

  • Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions

    In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.

  • Digital Health Apps In Europe — The Road To Reimbursement Goes Through Security

    In September, Spain’s National Cryptologic Center issued a road map to minimum security requirements for digital health applications and e-health mobile apps. This article highlights important recommendations from the 11 sections of the publication, serving as a preliminary checklist when preparing for market entry in Germany and/or Spain.

  • How To Implement Continuous Process Monitoring Of Validated Processes

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.


  • Infusion Therapy: Growth In Home And Alternate Care Sectors Supports Market

    The U.S. infusion therapy device market is a fairly saturated space, but that doesn’t mean opportunities for growth do not exist.

  • ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices

    Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.

  • How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

  • Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?

    Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

  • How To Prove (Or Improve) The Trustworthiness Of Your Medical Devices

    What objective evidence is necessary to show that your medical device performs as intended for its specific purpose, when needed, with operational resiliency, and without unwanted behaviors or exploitable vulnerabilities? These suggested activities will provide the type of information and objective evidence regulators require to prove the trustworthiness of a device.

  • ISO’s Updated 22442 Animal Tissue Standards — What Changed?

    This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).

  • ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices

    This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.

  • A Methodology For Developing Injection-Molded Plastic Parts For Your Medical Device

    This article describes a methodology that addresses the questions that have a reputation for being “troublemakers” in the process of injected plastic product development, without compromising innovation and creativity.

  • Generate The Right Input Data For A Quality Management Review System

    In this part two in a series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems, we turn our attention to the input data for an effective quality management review.

  • "Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap

    This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

  • Incorporating Privacy By Design & Security By Design Into Medtech Development

    Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.

  • Making FMEA More Robust With HACCP

    Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

  • Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities”

    How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”

  • Incorporating Injection Molded Plastics In Medical Device Design — Initial Considerations

    Even a great component idea can be undermined by gaps in knowledge surrounding plastic materials, from engineering and design considerations to optimal procedures for turning that idea into a reliable plastic part that can be consistently produced, affordably and with high quality.

  • MDR’s Impact On The European Trauma Device Market

    The MDR could prove detrimental to the EU trauma device market, while COVID-19’s impact should be minimal. Will key market drivers be enough to prompt growth?    

  • Implications Of COVID-19: EU MDR Implementation Update

    Learn how the EU 2020/561 Article 59 update, progress on guidance documents, formation of Expert Panels, and more affect your company. 

  • Paclitaxel-Coated Medical Device Markets Recovering After Difficult Year

    Despite recent positive evidence validating the use of paclitaxel in the peripheries, sales of devices that incorporate paclitaxel remain low. However, a turnaround appears to be on the horizon.

  • After COVID-19: Time To Rethink, Redesign, & Reprioritize Everything

    As we navigate the uncertainty ahead, two things are certain: 1) We will get through this, and (2) the post COVID-19 environment will be very different — but will it be better?

  • Identifying, Documenting, & Auditing Processes For Quality Management

    Process results that are predictable and consistent can be achieved more effectively and efficiently when the activities are considered, managed, and understood as interconnected processes that function as a system.

  • Navigating The FDA’s Emergency Use Authorization Process

    The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. 

  • Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards

    To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

  • Data Integrity In A Cloud-Based World: Regulations & Best Practices

    There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.

  • Is It Time To Say Goodbye To FMEA Risk Priority Number (RPN) Scores?

    It may be time to consider eliminating the use of the traditional risk priority number (RPN) score and transitioning to the use of action priority (AP) ratings. AP ratings are much simpler to use, do not require a calculation (eliminating the validation of a spreadsheet), and provides a single simple table reference to determine the appropriate level of action.

  • Pandemic Prompts Supply Chain Exodus From China — What’s Best For Your Business?

    Decisions made in panic rarely work out for the best. In lieu of abandoning operations in China completely, consider these alternatives to secure your company’s supply chain.

  • Ensuring Quality In Ventilator Production Scale-Up For COVID-19

    Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.

  • Stand By To Stand By: Organizational Contingency Planning

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.


  • Implementing Data Quality By Design For Improved Data Integrity

    We must adopt more planning in our data quality activities. This is data QbD in its simplest explanation, and we must include data integrity planning in those activities (e.g., considering how to meet ALCOA requirements).

  • India To Regulate All Medical Devices

    Expansion of notified device categories is poised to benefit savvy domestic and Western medical device companies by cutting out cut-rate operations.


  • Remote Auditing Best Practices For GMP Compliance

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

  • Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.

  • Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits


    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.


  • A SMART Approach To CAPA Effectiveness Checks

    Many times, corrective and preventive action (CAPAs) fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan.

  • The 10 Phases Of An Effective CAPA

    Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

  • Analyzing The Changes To Risk Management Standard ISO 14971:2019

    The third edition of ISO 14971 and its updated companion report are set for release this month. ISO 14971:2019 will provide clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles.

  • Design Of Experiments 101: Understanding DOE’s Foundational Elements

    DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.

  • What Does IMDRF’s New Cybersecurity Guidance Mean For You?

    Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.

  • People: The Most Persistent Risk To Data Integrity

    HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

  • SOP Remediation: When Reinventing The Wheel Is The Best Approach

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

  • FDA Updates Several 510(k) Guidance Documents

    The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

  • FDA Proposes Safer Technologies Program For Medical Devices

    This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.

  • India To Enhance Oversight Of Medical Devices

    India's Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices, is forming a new division that works exclusively with medical devices. Here’s what we know so far.

  • What Happens To ISO 13485 When Annex L Is Adopted?

    Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.

  • Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  • Examining FDA’s New Patient Labeling Draft Guidance

    The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

  • Is Your Personnel Hygiene Plan Up To Date?

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

  • MDSAP — History and Advantages

    The Medical Device Single Audit Program (MDSAP) has worked out its kinks and is poised for exponential growth, but it may be a while before the initiative makes headway in the EU and China.

  • What Your Organizational Design Says About Your Commitment To Data Integrity

    Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

  • U.S. Bone Repair Devices: Trochanteric Grip Market Stalls, Cerclage Cables Take Off

    Approximately 75,000 procedures were completed in 2018 using cerclage cables and trochanteric grips, devices used in the repair of broken or surgically altered bones. This procedure volume is increasing every year.

  • How To Prepare For An FDA Inspection

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.

  • 3 Surefire Approaches To SOP Harmonization

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  • AI, Data Integrity, & The Pharma Industry: Let’s Not Wait Until Someone Dies

    Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.

  • Developing A Set Of Usability Guidelines For Mobile Health Applications

    Most mHealth does not have to meet the FDA requirements for application of human factors and usability engineering. Thus – to date -- the processes used to design and assess mHealth have been widely variable and developer dependent.

  • “Work Harder” — And Other Ways To Completely Miss The Mark On Quality

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

  • A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 13485

    The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.