Content by Etienne Nichols
Understanding ISO 14971 Medical Device Risk ManagementWith the right processes, you don’t have to reinvent the wheel
Tue, 06/13/2023 - 12:02
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere. Every international regulatory agency you’ve ever…
Five Foundational Steps of a CAPA Quality ProcessA well-defined CAPA program is a framework for quality and effectiveness
Mon, 04/10/2023 - 00:02
I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices,…
Understanding the FDA’s Human Factors Guidance DraftWhat medical device manufacturers need to know
Mon, 03/06/2023 - 12:02
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in…
Process Verification vs. Process ValidationWhat’s the difference?
Tue, 02/21/2023 - 12:03
In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?…
Why Class 1 Medical Device Companies Need Design ControlEven if it’s not required, it’s critical
Wed, 09/14/2022 - 12:03
I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device CompaniesQuality management system regulation explained
Mon, 03/28/2022 - 12:03
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality…
Best Practices for an Effective Medical-Device Design Transfer ProcessMore than passing a baton
Wed, 01/19/2022 - 12:01
If you’re looking for information on medical-device design controls and product development, you can find a practically endless number of articles, videos, and podcasts with a few quick online searches. Yet with so much out there on these topics,…
The Hidden Cost of Building Your Own QMSAdopting an audit-ready, right-sized quality system without breaking the bank
Thu, 09/24/2026 - 12:07
Most early-stage medical device companies never decide to skip a quality management system (QMS). They just never decide to buy one. The founding team opens a shared drive, builds a spreadsheet for design inputs and outputs, starts a document…