Medical Devices
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.
The top 10 life science quality assurance consultants to work with in 2024
Need a life science quality expert on your side? We've assembled a crack team of the finest consultants to support your business in 2024.
The 9 top medical device consulting firms you should consider for 2024
We've hunted the top medical device consulting firms for 2024. Dive into the expert teams that can lift your medical device company to the next level.