Industry Perspectives - Design & Development

1. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

   We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

2. The Road To ISO 13485 Certification: Tips For Effective Audits 3/23/2023

   Follow these best practices to prepare for and conduct an audit for your medical device quality management system compliance with regard to ISO 13485.

3. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

   The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

4. The FDA Regulatory Landscape For AI In Medical Devices 3/3/2023

   This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the agency's priority list for releasing related guidances in 2023.

5. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions 2/28/2023

   The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

6. Medical Device QMS Cybersecurity: Threat Modeling 2/17/2023

   The FDA considers threat modeling fundamental in your premarket submission and expects you to include system level risks in its creation and deployment. But how do we go about threat modeling for our device? And how do we build the requisite QMS infrastructure and processes? This article shares a four-step strategy.

7. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

   The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

8. How To Close The Looming Life Sciences Data Storage Gap 12/9/2022

   Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.

9. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

   Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

10. FDA Vs. Congress: The Software Showdown 11/14/2022

    September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.