MDSAP Mock Audits – Getting QA and RA on the Same Page
As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the like. As companies grow, the scope of responsibilities narrows and people in QA and RA don’t interact as much as they should. That’s about to change and it’s being driven by one thing: MDSAP. As you may […]
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