Webinar: Getting Ready for QMSR

⌛QMSR is coming! Are you ready?
❗The FDA is about to issue the final notification of an imminent move to the Quality Management System Regulation (QMSR), which will amend the current Quality System Regulation (QSR) for medical devices to align with ISO 13485:2016 International Standard.
✅This will create a more explicit focus on risk management throughout a Quality Management System.
⌛Manufacturers will have 1 year to transition their current QMS to comply with the amended requirements of the QMSR.
➡️As a first step, let us review the risk-based requirements, both explicit and implicit, in ISO 13485:2016 so you can start assessing gaps in your current QMS.
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