Blog Archive: FDA

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The 510(k) Application: If Content is King, then Communication is Queen

Often, the first thing we hear from a consultant or a medical device company regarding an FDA 510(k) premarket notification is that it was delayed because the FDA reviewer did not understand something simple within the application, or completely…

MDSAP Device Marketing Authorization and Facility Registration

What is the Medical Device Single Audit Program (MDSAP)? The International Medical Device Regulators Forum (IMDRF) recognized that a global approach to auditing and monitoring the manufacturing of medical devices could improve their

Is a medical device accessory a medical device?

Rimsys' own James Gianoutsos recently contributed an article on discussing FDA's guidance document describing accessories and classification pathways. The guidance explains which devices FDA generally considers “accessories”

Podcast – Streamlining the MDSAP Device Marketing Authorization and Facility Registration Process

I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process. If you are not familiar with…