US FDA QMSR
Stay ahead with expert guidance on the US FDA’s new Quality Management System Regulation (QMSR) and the broader regulatory requirements for the US market. We can provide a roadmap covering all necessary areas for successfully entering the US market.
Quality Management System Regulation (QMSR)
To enter the US market, it is mandatory for manufacturers to have a Quality Management System (QMS) that:
- Complies with the FDA Quality Management System Regulation (QMSR), ensuring alignment with ISO 13485 plus FDA-specific requirements.
- Has effective post-market processes, including complaint handling, MDR reporting, and corrections & removals as detailed by the FDA.
- Ensures supplier and distributor controls meet FDA requirements.
- Continuously monitors and implements new FDA guidance and regulatory updates.
Let our experts support you in:
- Planning the QMS together with the manufacturer according to the QMSR regulation and additional regulatory requirements.
- Identifying all processes or updates needed for the QMS
- Preparing the Quality Manual, QMS process descriptions, templates, databases, and other documentation needed together with the manufacturer.
- Choosing and implementing an electronic QMS when needed
- Maintaining and continually improving your QMS
- Daily QMS activities including nonconformances, feedback, complaints, internal and supplier audits, vigilance, and many others.
- Offering custom and open training for medical device QMS
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US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
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