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MDR Audit Readiness
– Prepare for your MDR* certification Audit
*MDR - EU Medical Device Regulation
Completed 26 May 2020. Available as streamed video.
- Which parts of my 13485 certified-quality system need to be updated and how?
- How do I establish an efficient feedback loop between Risk management, Clinical evaluation and Post-Market Surveillance without creating “document overload”?
- As legal manufacturer, am I responsible to inform distributors about their new responsibilities?
- What is my responsibility as subcontractor/contract manufacturer towards a legal manufacturer?
- How is the MDD certificate grace period affected by the MDR delay?
After this 2-hour webinar you will be better equipped to tackle the questions above. We’ll walk you through the key MDR requirements on the Medical Device quality management systems and provide you with tools to perform an efficient MDR gap analysis of your quality system. The relationship between ISO13485:2016 and MDR will be discussed and the MDR requirements that are not covered by the standard pointed out.
The requirements posed on specified roles such as authorized representative, importer, distributor and “legal” manufacturer will be discussed as well as how to define and document relationships to other parties, i.e. AR, subcontractors, suppliers and between an OBL manufacturer and the OEM.
Finally, we will cover how the interrelation between clinical evaluation, risk management and post-market surveillance can be demonstrated in your quality system.
Completion of this course will give you the knowledge needed to assess and update your current quality management system for MDR compliance.
Who should attend:
The course is suitable for persons involved in, or responsible for the operation or audit of a Quality Management System for medical devices who need to know the changes that comes with the implementation of the Medical Device Regulation.
Need of prior knowledge/experiences
- You should have good knowledge of medical device quality system from working with MDD or ISO13485.
You should have at least 2 years of experience from the medical device industry.
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Symbioteq Kvalitet AB
Recording from 26 May 2020
Price (excl. local VAT):
Recording: 250 Euro
The video is available for 30 days.
Course handouts (PDF) included.
How to access the video:
You will receive a private link by email to the video at Vimeo.com. The video can only be streamed online (not downloadable).