Edwin Bills

Edwin Bills is a consultant, ASQ Fellow, Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager, and is Regulatory Affairs Certified. He provides contracted services in the area of quality systems, regulatory affairs, product liability, and risk management for medical device, combination product, and pharmaceutical companies.


  • The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR

    The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.

  • What Does EN ISO 14971:2019's New Amendment Mean For Harmonisation?

    CEN, the European standards body, recently released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This article examines the amendment and discusses what this means with regard to harmonisation with the MDR and IVDR regulations in Europe.

  • 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.

  • 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.

  • 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.

  • 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.

  • ISO 13485 Medical Device Quality System Standard And Other Regulatory Conundrums

    ISO 13485 is up for periodic review, and the ISO Technical Management Board has indicated that standard should be revised to comply with the new High-Level Management System Structure (MSS) for all documents of this type. The 2015 version of ISO 9001 is in the new structure, and it is organized in a vastly different format. 

  • A Look At The ISO 14971 And ISO TR 24971 Updates

    How will changes to the ISO 14971, the medical device risk management standard, and its accompanying guidance document, ISO TR 24971, an ISO Technical Report, affect your company?