Industry Perspectives - Design & Development

1. Risk Tool Selection With ICH Q9(R1) In Mind 9/19/2023

   This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

2. FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready? 9/18/2023

   The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?

3. A Brief Guide To ISO 13485’s Design Controls In Medical Device Development 9/15/2023

   Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.

4. The Critical Role Of Risk Mitigation & Vertical Integration In Successful Micro Molding 7/31/2023

   In this exclusive Q&A article, Alex Anderson, Sales Engineer at Accumold, systematically explores the crucial implications of vertical integration in micro molding projects.

5. Steps To Develop A Leak Test For Implantable Medical Devices 7/7/2023

   If you're developing an implantable medical device, you need to prove to regulators that it will function safely and effectively 10 years after implantation. However, there is no standard approach to follow, and before setting acceptance criteria, you'll need to find a way to test for leaks. Here is one effective method.

6. Combination Product QMS Requirements For The EU Market 6/30/2023

   Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

7. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

   Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

8. Quality Engineers: Are You Making The Right Call? 6/1/2023

   As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?

9. The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR 5/24/2023

   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.

10. The Role Of Failure Mode In ISO 14971:2019’s Hazard-Based Approach 5/10/2023

    In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.