The Ins and Outs of Post Market Surveillance Under the EU MDR – Webinar

• What: Webinar – The Ins and Outs of Post Market Surveillance Under the EU MDR
• When: Tuesday, July 13^th at 10 am (EST)
• Where: Online Event
• How: Register online now.
• Why: Join us to examine the Post Market Surveillance (PMS) requirements under the EU MDR and what manufacturers must do to stay compliant.

Expanded Post Market Surveillance (PMS) requirements is a major hurdle that the EU MDR presents. Notified Bodies will be expecting a far greater amount of Post Market Surveillance data, and device manufacturers must improve their PMS systems and processes to adapt.

Join this featured presentation to understand our Device RA/QA Subject Matter Expert, Joseph-Richardson Larbi’s perspective on the Post Market Surveillance (PMS) requirements under the EU MDR, and what manufacturers should consider for future compliance.

Celegence will be hosting the WEBINAR on Tuesday, July 13^th at 10 am EST. Register online now here!

Joseph-Richardson Larbi has 18 years of experience in Medical Device (MD & IVD) Regulatory and Quality strategies (from design and development to market launch and post marketing activities – compliant to MDD/MDR/IVDR/ISO 13485/9001 Quality Management Systems).

He is experienced in CE certification, ISO 14971 Risk Management, Manufacturing and Supplier Management, Manufacturing Verification and Validation, Post Market Surveillance, Clinical Evaluation Reports, Drug Device Combinations, regulatory relationship management, and advance knowledge of FDA Drugs, Biologics, and Biosimilars (IND, NDA, BLA).

This webinar will cover:

• The purpose of PMS in the EU MDR
• How to set up an effective PMS system
• How the PMS system should integrate with other systems
• How to keep your PMS system up to date
• Reporting requirements and other PMS obligations of the manufacturer

Upon conclusion of the program, you will be able to:

• Understand the best practices relating to implementing a compliant EU MDR PMS requirement
• Learn how the requirements could affect your current product lifecycle approach/QMS
• Listen to Joseph’s practical tips and guidance for implementation
• Examine examples and relevant case studies
• Have your most pressing questions answered during the Q/A session

This webinar would support those working for companies in the life sciences, including manufacturers of medical devices, with a special emphasis on:

• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Medical Device Executives
• Technical Writers and Managers
• Medical Device Design Managers
• Clinical Managers
• Authorized representatives in Europe

The Ins and Outs of Post Market Surveillance Under the EU MDR webinar will be held on Tuesday, July 13^th at 10 am EST. Make sure you secure your spot at the webinar by registering now.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing, and health authority interactions. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you during this webinar and hope that you can join us then.