Articles From Our Expert Network
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How To Set Up An Effective Quality Risk Management Program
2/16/2022
The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.
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FMECA: Relevance In Context Of ISO 14971 & EU MDR Compliance
2/9/2022
This article focuses on failure modes and effects and criticality analysis (FMECA) and the hazard-based approach in ISO 14971. It uses these definitions and discussions to illustrate EU MDR compliance, and how a top-down approach of FMEA can help.
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These Spinal Implant Devices Are Seeing A Resurgence In The Asia-Pacific Market
2/2/2022
There are three major types of implants used: metal-based interbody implants, polyetheretherketone (PEEK) devices, and machined bone interbody devices. This article provides an explanation of each, and shares which type is seeing a resurgence in the Asia-Pacific market. Additional insights are discussed, including the rise of 3D printing and local manufacturing.
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The Technological Advancements Driving The EU’s Urology Device Market
12/22/2021
In response to new demands, there has been an enormous uptick in minimally invasive procedures. New technology is being developed in many important segments of the urology market, especially in the urological endoscope market. In Europe, there is an incentive to use a disposable scope, for example. Trends and technological advancements in Europe's urology device market are covered in this article.
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The Data Integrity Body of Knowledge Expands with New & Pending Guidances
12/20/2021
Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.
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Using System Risk Structures To Evaluate COVID-19 Pandemic Risks
12/15/2021
This article's discussion demonstrates how system risk structures (SRS) can be used to understand complex risks and how SRS might be applied to understand the very complex risk landscape of the COVID-19 pandemic. It includes analysis of risk of personal infection, risk of disease progression or spreading, risk of vaccination, and more.
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Principles And Concepts Of System Risk Structures For Understanding & Managing Risks
12/6/2021
A truly effective risk analysis method for the biopharma industry should provide insights to and understanding of the fundamental properties and attributes that underlie every type of risk. This article describes how system risk structures (SRS) can be used to understand and manage both simple risk situations as well as complex risk landscapes quickly and efficiently.
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Use Of Wearable And Sensor Applications In Clinical Trials Is Booming
10/26/2021
Experts predict 50% of clinical trials will incorporate wearables and sensors by 2025, compared to the 10 to 15% at present. This article shares market research on the use of wearables and sensors in clinical trials, including smartwatches, ingestible sensor-embedded pills, and more.
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Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications
10/22/2021
While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.
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COVID-19 Vaccine Benefit-Risk Analysis/Ratio Using Real World Data
10/6/2021
For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric articles such as this one, covering a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. The article provides a relevant, contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.