New European Medical Device Regulation (MDR) 2017-745

This webinar will discuss main differences between current EU Medical Device Directive (MDD) 93/42/EEC and new EU Medical Device Regulation (MDR) 2017-745 and how to ensure compliance with the new MDR requirements that will be mandatory starting May-2020.

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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Mar-2020

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(PPT + Recorded Training File)

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Downloadable link along with the materials will be emailed within 2 business days
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Why Should You Attend:

Only medical device companies that are in compliance with the new Medical Device Regulation (MDR) 2017-745 will stay in the European market after 26-May-2020. It's key to understand the gaps with the previous Medical Device Directive (MDD) 93/42/EEC and how to remediate them to continue business in the 2nd (about 30 % worldwide volume) worldwide medical device market.

The webinar will discuss in detail how to address the gaps between MDR and MDD in the areas of:

  • Device classification
  • Conformity routes
  • General Safety and Performance Requirements (GSPRs)
  • Technical documentation
  • Post market surveillance (PMS)
  • Clinical evaluation
  • UDI
  • Economic operators
Areas Covered in the Webinar:
  • Device classification
  • Conformity routes
  • General Safety and Performance Requirements (GSPRs)
  • Technical documentation
  • Post market surveillance (PMS)
  • Clinical evaluation
  • UDI
  • Economic operators
Who Will Benefit:
  • Quality Assurance Managers / Directors / VPs
  • Regulatory Compliance Managers / Directors /VPs
  • Regulatory Affairs Managers / Directors / VPs
  • Clinical Managers / Directors / VPs

Medical Device industries conducting or planning to conduct business in the European Union

Free Materials:
  • Reference documents
Instructor Profile:
Juan M Campos Juan M Campos

Owner, JMC Medical Device Consulting

Juan M. Campos is a Medical Device professional with + 32 years of continued industry experience. His main areas of expertise include Quality Assurance, Regulatory Compliance and Regulatory Affairs. He has led culturally and geographically diverse QA/RA teams in Spain, UK, France, Switzerland, Netherlands, Germany, Portugal, Italy, Greece and Turkey directly reporting to him. Additionally he has successfully coordinated global QA/RA projects with extended on site presence in USA and China. Most of the Regulations that govern today’s Medical Device world (EU Medical Device Directive, US FDA CFR 21-820, ISO 13485, Japan MHLW, Australia TGA, Brazil ANVISA, Health Canada, China SFDA, etc) have been created, implemented and even revised several times during Juan’s 30 year daily industry activity in leadership QA/RA roles. Specifically Juan has successfully led both product international Regulatory Registration processes, together with Regulatory Compliance global projects to ensure full Quality System compliance with those Regulations (Quality System design and implementation, Regulatory Agency pre-inspection readiness, Regulatory Agency post-inspection remediation, M&A due diligence and post-merger integration, product quality claims & liability, etc) in manufacturing, subcontractor and distribution facilities around the globe. Juan is also a certified SGS ISO 9001 Auditor, BSI ISO 13485 Lead Auditor and SGS MDR QMS Auditor & Product Assessor with extensive EMEA, China and USA on site audit experience, an active voting member of ISO TC150 CTN91 Implants and ISO TC210 CTN111 SC3 Quality Management Committees, as well as an active project evaluation expert at the BioExpert Network.

Refund Policy

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. FDATrainingAlert 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.

If you have any concern about the content of the webinar and not satisfied 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 call +1-888-771-6965 (Toll Free).

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