AMA on MDSAP


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This week we’ve invited @Danny Kroo from Docusys for an exclusive AMA (ask me anything) session with the community concerning the topic of the Medical Device Single Audit Program (MDSAP.)

We hope you find this session informative and engaging!

If you have any feedback or suggestions, send a message directly to @Etienne and let us know!

 

 

Jaymie Hu 4 months ago

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Who should get MDSAP certified. I know where/when it's required. But at what point should we pursue it? Early? Later? When is the right time?

Companies that want to sell to Canada need to get MDSAP certification. 

You should apply when you feel your quality system is ready for an audit.

FDA:

https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms

 

J.H

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Thank you, @Jaymie Hu - great share!

Rob Packard was a great mentor and taught me the essence of medical device regulations and quality.

 

He posted a great video on Youtube:

 

 

Six steps to ISO 13485:2016 Certification and MDSAP Certification

 

I’ve attached a PDF that I wrote based on Medical Device Academy’s video. 

Thank you Rob.

Jaymie Hu

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Can a manufacturer have an MDSAP and ISO 13485 audit conducted at the same time?

Yes, it is a “combined audit” - both audits at the same time.

Make sure that you consider the upsides and, potential, downsides of doing a combined audit. There is, FOR SURE, a strategy here to consider - this includes your level preparedness and understanding that the MDSAP audit report gets sent to the regulatory agencies of the 5 participating countries. (!!!)

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