Industry Perspectives - Design & Development

1. What Happens To ISO 13485 When Annex L Is Adopted? 9/16/2019

   Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.

2. Understanding Costs And Risks For Human Factors Engineering (HFE) Usability Studies – Part 2: Outsourcing HFE Usability Testing 5/6/2019

   This article -- the second in a two-part series -- examines how to navigate the complex problem of optimizing data quality while controlling for study costs and time constraints when employing independent HFE testing agencies.

3. Cybersecurity Bill Of Materials For Medical Devices: What’s Next? 4/1/2019

   In October, the U.S. FDA published an updated draft of Premarket Cybersecurity Guidance and introduced the concept of a cybersecurity bill of materials (CBOM) for medical devices. Some medical device manufacturers have since raised concerns regarding mandating CBOMs in the 510(k) or premarket approval packet.

4. Chief Quality Officers: Redesigning Quality For The 21st Century 3/27/2019

   With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

5. How The FDA’s Pre-Certification Pilot Program Is Paving The Way For AI In Medtech 3/11/2019

   The FDA’s Software Precertification (Pre-Cert) Pilot Program aims to move away from the traditional 510(k) and De Novo pathways, and to develop a program better suited for technologies that have a rapid development and update lifecycle.

6. Why Data Integrity Is Impossible Without A Quality Culture 2/19/2019

   For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

7. Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House 1/14/2019

   Given the costs, risks, and complexity of human factors engineering (HFE) usability testing studies, are you better off conducting such studies internally, or retaining a formal HFE testing agency?

8. Separating, Optimizing Device Evaluation And Design Verification A Key To Medtech Success 1/9/2019

   In medical device design and development, two critical development activities — device evaluation and device design verification — often are treated as one, and this behavior is shockingly detrimental to successful medical device development.

9. Data (Integrity) Pirates: Preventing And Detecting Malicious Intent 10/22/2018

   During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?” 

10. FDA: Case For Quality Collaboration 9/13/2018

    We needed to find out — in the Case For Quality Program in particular — how to get that enforcement fear out of the equation, so we could avoid the front-room/back-room concept and drive improvement.