There are a few additional steps to take when it comes to the Medical Device Single Audit Program (MDSAP) and ISO 13485-2016 regulatory process to get appropriate marketing clearances or approvals.

If you go through a regulatory process and get a product cleared, you still need to make sure your product is properly registered with the appropriate regulatory agencies. These extra steps to actually sell your product can be complicated.

On today’s episode, I talk to Jim Gianoutsos of RIMSYS Regulatory Management Software, about how to improve and streamline the device marketing authorization and facility registration process to gain efficiencies.

Some of the highlights of the show include:

●To be a global leader or company, you need to have a solid system in place to manage marketing authorizations worldwide.
●As part of the MDSAP process, you’re expected to answer specific questions and show evidence of compliance.
●Your regulatory team may be perceived as a bottleneck. Everyone needs to be on the same page about when the product can be released.
●Connection between marketing authorization and facility registration required for various countries - United States, European Union, or elsewhere.
●Get organized, have systems in place, and stay in compliance in case an auditor comes through your door or if you plan to sell in particular markets.
●FDA is moving away from 21 CFR 820 regulations to adopt ISO 13485 as quality system requirements via an MDSAP audit.
●Small companies have too much information to maintain, organize, and track. Large ones may have resources, but suffer from miscommunication.
●Don’t be complacent or afraid to change systems. RIMSYS was created to help regulatory professionals successfully and efficiently handle documentation.