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(0 critiques) See Profile High quality administration Resolution created for life sciences companies to deal with compliance and regulatory processes.
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Most certainly. Even if you plan to outsource ALL manufacturing, the FDA and other agencies will keep you to blame for solutions you put in the marketplace. If an incident happens with all your item, the regulatory authorities aren't going to examine your subcontractor, they can inspect your Corporation given that the authorized entity for marketing the device.
They could currently be compliant with ISO 13485 and/or FDA QSR; having said that, you need to assure their high quality technique is adequate to supply superior quality factors or safe and successful completed medical devices.
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It really is more than likely that a chosen subcontractor is creating components or creating the whole completed devices For several medical system organizations.
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There are numerous case research and examples on this site: Medical machine top quality management technique software
Regardless that it may be remote chance, the FDA can however choose to inspect your subcontractor If you don't have the appropriate provider controls established.