Regulatory & Compliance Perspectives

31. 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.

32. 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.

33. 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.

34. 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. 

35. 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.

36. Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management 12/22/2020

    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.

37. Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach 12/15/2020

    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.

38. Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation 12/11/2020

    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.

39. Brexit Finalization: How Will Medical Device Compliance Change In Europe In Jan. 2021? 11/23/2020

    The UK's transition period in leaving the European Union ends on December 31, 2020. The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical devices marketed in the UK, released new guidelines in September 2020 detailing how devices will be regulated beginning January 1, 2021, with varied compliance dates for different device classes.

40. ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO 14971 11/19/2020

    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.