EU-MDR: Are You Ready? Part II – Webinar Recording/Transcript
EU-MDR: Are You Ready? An Exclusive Three-Part FDAnews Webinar Series
Part II: Tips for Assessing Your Readiness Prior to Notified Body Review
With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by the end of May. This postponement will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.
— European database on medical devices (EUDAMED)
The EU-MDR increases patient safety by making products more readily traceable.
You’ll need to make sure that the product information — including labeling content — is current on your website. And that the unique device identification for all your devices is uploaded to the European database on medical devices (EUDAMED).
Does your organization have the right strategies in place for a notified body review?
Join us for a webinar on April 10 for a discussion of the Plan-Do-Check-Act cycle where you’ll need to conduct internal audits for each EU-MDR element. In 90-minutes, medical device expert, Dan O’Leary will explain the relevant parts of Annex VII and how to integrate them into the internal audit program.
- Audit the Quality Management System (QMS) elements in Article 10
- Review of the Annex II technical documentation supported by Annex I and Annex III
- Understand the requirements for the Annex IX application
- Recap the notified body document review in Annex VII
- Understand the notified body audit based on Annex VII
Make sure you have the right strategies in place for regulatory compliance with the rigorous EU-MDR mandates!
The series includes:
- Part III: Ensuring Your Postmarket Surveillance Readiness
Thursday, April 23, 2020, 1:30 p.m. - 3:00 p.m. EDT
- Part I: The Real Role of the Person Responsible for Regulatory Readiness & Compliance
Recorded on Thursday, Feb. 20, 2020. Purchase as a Webinar Recording/Transcript.
Meet Your Presenter
Dan O’Leary, President, Ombu Enterprises, LLC
Your webinar leader is Dan O’Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit
- Medical device / technology companies
- Quality manager
- Regulatory manager
- Operations manager
- Design manager
- Technical manager
- Clinical manager
- Authorized representative in Europe