What: Webinar – “Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR”
When: Tuesday, November 15th, 2022, at 10 am CT
Where: Online Event
How: Register Here
Why: This webinar will illustrate how the FDA rollout of the new Quality Management System Regulation (QMSR) to replace the current Quality System Regulation (QSR) will impact the medical device and in vitro diagnostic industry.
FDA issuance of the new Quality Management System Regulation (QMSR) to industry is meant to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) with an incorporation by reference (IBR) to the 2016 edition of ISO 13485. FDA adoption of the ISO standard comes with some modification to maintain its statutory and regulatory framework. The transition is meant to be seamless as the ISO requirements are substantially similar with the QSR, however, such transition doesn’t go without possible impact to the existing QMS for integration and implementation of the new regulation.
This featured presentation will be led by Brian Nquyen, Celegence’s Subject Matter Expert, Medical Device RA QA. Brian will also be available following the presentation for a live Q/A session.
Celegence will be hosting the WEBINAR on Tuesday, November 15th at 10 am CT. Register online now!