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We are less than three months away from the deadline for medical device compliance to the new EU MDR Regulation (EU 2017/745), which will require compulsory assessments by your notified body to determine how well your systems comply to this new regulation.

Are you sure you're ready? We've heard loud and clear an abundance of last-minute issues and questions.

This webinar is the premier opportunity to learn from seasoned industry and notified body experts as they share their experiences with preparing, performing, and managing audits, as well as remediating nonconformances.

While there have been and will continue to be plenty of implementation challenges with EU MDR and the expectations for audits, these R&Q Vice Presidents have worked through some comprehensive guidance on what to expect during an EU MDR audit and how to strategically prepare and manage it.

 Here's a summary of topics to be covered during the webinar:

– Getting fully prepared for your notified body audit

  • Are your quality systems compliant to ISO13485:2016 and the EU MDR requirements?
  • Do you have adequate staffing to plan for the audit and an established process to manage it?
  • Training on how to interact with auditors

– Managing the audit

  • Have you established the strategy to actively manage the audit: The Notified Body audit plan provided in advance, who will manage the auditors, SMEs to cover specific areas and topics?
  • What to expect during the audit.

– Responding to audit nonconformances

  • Does the organization understand the expectations from your Notified Body regarding the resolution of nonconformances?
  • How will you internally manage the response to the Notified Body and assure it adequately addresses the nonconformance?

 

If you want guidance to help you understand and effectively prepare, manage, and conclude with a successful EU MDR audit, this is the definitive session for you.

 

Presenters

Ibim Tariah, Ph.D. – Vice President of EU MDR and IVDR Consulting Services
Regulatory & Quality Solutions (R&Q)

Ibim_Tariah_SquareDr. Ibim Tariah earned his PhD in Materials Science the University of Manchester, U.K.  Dr. Tariah has over 30 years experience in the medical device industry, including 21 years at BSI. In Dr. Tariah's role of VP of EU MDR/IVDR Consulting Services at R&Q, he provides leadership, strategic advisement and implementation expertise to R&Q's consulting team and medical device clients. Prior to R&Q in his role of Technical Director of Medical Devices for BSI Americas, Dr. Tariah was part of the BSI Americas leadership team responsible for transitioning from MDD to MDR certification. Dr. Tariah recognized the significant challenges in implementation of the EU MDR. He created and led customized MDD and MDR workshops for clients and industry, and spoke on behalf of the notified body at global conferences and events.

For more information about Ibim's experience and role at R&Q, read his interview here.

 

Ralph Asencio – Vice President of Technical Services
Regulatory & Quality Solutions (R&Q)

Asencio_Square-min

Ralph's background includes over 30 years of leadership experience in the medical device and IVD industry with leaders such as Philips Healthcare, GE Healthcare, Baxter, Beckman Coulter, and Edwards Lifesciences; in the commercial areas of diagnostics, patient monitoring, ventilation, renal therapy, sleep apnea, oxygen therapy, asthma, and coronary catheter products. In his role as Vice President of Technical Services at R&Q, Ralph helps expand our technical service offerings, build more strategic partnerships with core clients, expand regulatory intelligence and education offerings to clients, and provide technical guidance and business leadership across the board.

For more information about Ralph's experience and role at R&Q, read his interview here.