Industry Perspectives - Design & Development

91. How Do I Need To Update My QMS For FDA QMSR Amendment Compliance? 3/23/2022

    The FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices. This article describes what you need to do with your QMS in order to meet compliance.

92. FDA Seeks Public Comment On Quality Metrics Reporting Program 3/17/2022

    The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

93. Medical Device Packaging Labels 101 3/16/2022

    Medical device labels play an important role in a device’s life. They are key to market introduction and success, a company’s long-term financial viability, and to patients’ health and lives. This article provides advice for getting the label right the first time to avoid product recalls and for the best chance of product success.

94. FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations 3/8/2022

    Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.

95. What Does EN ISO 14971:2019's New Amendment Mean For Harmonisation? 3/4/2022

    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.

96. What's The Role Of Intuition When Making QRM Decisions? 2/28/2022

    In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

97. FDA Issues Proposal To Amend The Medical Device Quality System Regulation 2/24/2022

    The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016. The proposed amendment will also affect 21 CFR Part 4: Regulation of Combination Products.

98. What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices? 2/23/2022

    This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.

99. 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.

100. 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.