Implications Medtech Companies FDA Rollout QMSR Replace QSR - Celegence

Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR – Webinar

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.

Webinar Background

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! 

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EU MDR - Celegence Life Science

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Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

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Webinar Featured Presenter – Brian Nguyen

  • Brian has worked in the medical device industry for more than 25 years in companies of varying sizes with class I, II, III devices.
  • He contributed to start-up and major medical device companies in building and maintaining the Quality System.
  • He has a Bachelor in Engineering and Masters in Business Administration and has certification to ASQ: CQA, CQE, CQM/OE, CMDA, CSQP and Certified auditor/lead auditor ISO 9001:2000/ISO 13485:2016 Dekra/Exemplar formerly RABQSA.
Brian Nguyen - Celegence Webinar MedTech

Webinar Learning Objectives

  • Hear Brian’s key insights into the new QMSR
  • Examine examples and relevant case studies
  • Have your most pressing questions answered during the Q/A session

Who Should Attend?

This webinar is aimed towards those working for companies in the life sciences industry, particularly manufacturers of medical devices and IVDs, with a special emphasis on:

  • Dx Clinical & Regulatory
  • EU Dx Clinical & Regulatory
  • EU MD & Dx Quality
  • EU MD Regulatory
  • MD Quality
  • MD Regulatory
  • MD Supplier Quality

Webinar Sign Up

“Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR” webinar will be held on November 15th, 2022, from 10:00 am – 11 am CT. Make sure you secure your place at the webinar by registering now.

Services for Medical Device IVD Manufacturers

Full Spectrum Services for Medical Device and IVD Manufacturers

Celegence provides the medical device and diagnostic industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR and EU IVDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.

We are happy to share our insights with you during this webinar and hope that you can join us then. Reach out to us at info@celegence.com to learn more, contact us online or read more about Celegence’s medical device and IVDR services.

Celegence’s comprehensive support for creating and maintaining required documentation can help ensure your organization’s IVDR compliance. Reach out to us at info@celegence.com, contact us online or read more about Celegence’s IVDR services.