Guest Columns

1. Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean? 1/27/2021

   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. 

2. With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices 1/25/2021

   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?

3. Closing The Loop On Risk Management With ISO 14971:2019 1/22/2021

   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.

4. Avoiding ISO 14971 Mistakes — Are You Accurately Defining “Hazardous Situations”? 1/20/2021

   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.

5. 4 Steps To Kick Off Your Mold Production Project For Success 1/18/2021

   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.

6. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

   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.

7. Avoiding ISO 14971 Mistakes — Do You Really Understand The Term “Hazard”? 1/13/2021

   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. 

8. An Introduction to Polymeric Materials for Medical Devices 1/11/2021

   What's the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and chemistry, and a process for material selection for specific applications, focusing on thermoplastics. And stay tuned for future follow-up articles that do a deep dive on polymers for coronary angioplasty, point-of-care testing and wearables, ophthalmic applications, and drug delivery!

9. Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues 1/8/2021

   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.

10. Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending 1/6/2021

    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.