New European Medical Device Regulation (MDR) 2017-745

Speaker

Instructor: Juan M Campos
Product ID: 706302
Training Level: Intermediate to Advanced

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Mar-2020

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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
  • EUDAMED
  • 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
  • EUDAMED
  • 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.

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