How to Prepare for the New EU Medical Device Regulations


Instructor: Richard Young
Product ID: 705513

  • Duration: 90 Min
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
Last Recorded Date: May-2018


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
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Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
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Why Should You Attend:

In the wake of well publicized issues in the regulation of medical devices in Europe, including metal- on-metal hip failures and the PIP breast implant scandal, the new European Medical Device Regulation was published in May of 2017. The new regulation expands the definitions of controls within the market for manufacturers, Importers, distributors and authorized representatives as well as applying stringent new controls to Notified Bodies. The impacts of these changes can already be felt throughout the industry.

The Medical Devices Regulations are due for significant update with areas such as Post Market Surveillance and Economic Operators being major areas of change. The final form of the regulations is now set and due to be voted into European Law. The new regulations need to be considered now at all organizational levels as they will be impacting on decisions taken today.

This webinar is designed for business leaders with executive responsibilities. This course quickly identifies the areas of strategic impact, possible costs and the time lines associated with the new EU Medical Device Regulations. The main impact areas are identified and discussed with possible approaches and budget and timeline considerations. Get ahead of the curve and ensure you organization has a solid basis for managing this transition and ensuring that key products have continued market access in the EU.

Areas Covered in the Webinar:

  • Review of the structure of the new regulation
  • Overview of impact areas of regulatory change
  • Details examination of :
    • Product Classification
    • Clinical data PMS and PMCF/clinical evaluation reports
    • Transition arrangements
    • Technical documentation requirements
    • Unique device identification
    • Economic operators
    • Technical data including risk management

Who Will Benefit:

  • Quality Managers
  • Regulatory leaders
  • Business Strategy Leaders
  • R&D Leaders
Instructor Profile:
Richard Young

Richard Young
Managing Director, Acclaim Biomedical Consulting Ltd

Richard Young (BSc (Hon) MSc, AIQA, ) Managing Director of Acclaim Biomedical Consulting Ltd, has worked in the Medical Device and In Vitro Diagnostic markets for over 25 years with a personal focus on regulatory compliance, process validation and risk management.

Richard has been an active member of many groups through his time in industry, including representing industry in the formation of the “beyond compliance initiative” and spending many years on the Eucomed Standards Focus Group as well as standards groups such as LBI 35.

Over the last few years, his consulting activities have included a large proportion of training and education including teaching at Sheffield Hallam University in the UK on a Post Graduate Diploma Course.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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