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Recorded Webinar
Preparing for and Managing EU Notified Bodies Audits as a Result of EU Commission Recommendation 2013/473/EU
timelapse 90 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This is a detailed webinar designed to provide medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced Notified Body (NB) audits. The webinar will provide attendees with the major changes in CE certification as it relates to unannounced audits and other associated topics, as a result of EU Commission Recommendation 2013/473/EU. It also explains the impact this recommendation has on manufacturers, NBs, subcontractors, suppliers and service providers. Furthermore, it provides background information on NBs purpose and CE marking. It will walk you through, the rationale, strategies and flow on how to plan for the audit, the audit process and approach, and which company roles should be assigned for Notified Body audits, including each of their responsibilities.
The presentation will cover the following areas:
- Purpose of Notified Bodies Audits
- Steps to take in order to meet EU Compliance
- Relationship Between Certifications, Product Registrations, and ISO 13485 standard
- Common Versions of ISO 13485
- The difference between a Notified Body, Certification Body, Conformity Assessment Body and a Registrar
- Frequency of Notified Body Audits
- Where to Find Most Current List of EU Notified Bodies and Contact Points Within the National Competent Authority per Country for Medical Devices
- Changes and Adverse Events, Who to Notify
- Major Changes in Medical Device CE Certification Related to Unannounced Audits and Other Matters
- Preparation for a Notified Body Audit
- Audit Process: What to Expect From Notified Body’s Arrival Up to Their Exit
- Timelines to Respond to Notified Body’s Audit Reports and Sequence to Follow in Your Response
- Challenges
- Conclusions
- References
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