Content by Etienne Nichols
What FDA QSR and ISO 13485 Harmonization MeansQMSR for medical device companies
Wed, 08/09/2023 - 12:03
On Feb. 23, 2022, the U.S. Food and Drug Administration (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)…
Making the Business Case for a New QMS SolutionAn eQMS buyer’s guide
Tue, 08/01/2023 - 12:03
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under…
Fifteen Questions to Ask QMS Software Vendors in the Medical Device IndustryThe answers will reveal the truth about your product and get it to market faster
Wed, 07/26/2023 - 12:02
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management…
How to Develop a Risk-Based Approach to Supplier ManagementDoing what’s best for your devices as well as your business
Wed, 07/05/2023 - 12:03
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications. But achieving that goal is easier said than done, and it depends…
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…