Medical Devices
What is the FDA QMSR?
The FDA plans to align 21 CFR 820 and ISO 13485. There are a number of steps that will be taken to achieve harmonization — here's what you need to know.
25 impressive medical device startups to watch in 2026
Get the full list of medical device companies who are shaping the industry this year. Wonderful inventions, lifesaving products, and more.
A complete guide to 21 CFR Part 11 for medical device manufacturers
21 CFR Part 11 governs electronic records & electronic signatures. Learn what medical device manufacturers must know about 21 CFR Part 11 to be compliant.
Your complete guide to the Medical Device Single Audit Program (MDSAP)
Learn how the Medical Device Single Audit Program (MDSAP) streamlines regulatory compliance for five major markets, with tips for certification and preparation strategies.
Overview of ISO 14155
Discover how ISO 14155:2020 ensures ethical compliance and scientific validity in clinical investigations for medical devices. Learn key requirements and best practices for certification.
Ultimate guide to the IEC 62304 standard
Learn everything about IEC 62304, the essential standard for medical device software development, from certification steps to practical implementation tips.
Understanding post-market surveillance for medical devices
Post-market surveillance (PMS) helps you capture feedback about your medical device. Learn how to create a PMS plan and run a successful post-market surveillance program.
ISO 13485: the essential guide
Review the key elements of ISO 13485 and how to successfully prepare for ISO 13485 certification.
What is design control for medical devices and how does it work?
Discover how design control ensures quality in medical devices. Learn about FDA guidance, documentation, and the design control process flow chart.
What the FDA's MDDS guidance means for you
Things have changed since the FDA's Medical Device Data Systems (MDDS) Rule in 2011. The 2022 guidance changes how MDDS are defined and regulated in the medical world.