Duration: 60 Minutes


Purchase Options: *

Learn More

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.

Areas Covered in the Session :

  • Device classification
  • Conformity routes
  • General Safety and Performance Requirements (GSPRs)
  • Technical documentation
  • Post market surveillance (PMS)
  • Clinical evaluation
  • UDI
  • Economic operators

Who Should Attend:

  • Quality Assurance Managers / Directors / VPs
  • Regulatory Compliance Managers / Directors /VPs
  • Regulatory Affairs Managers / Directors / VPs
  • Clinical Managers / Directors / VPs

Course Director: JUAN M. CAMPOS

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, the UK, France, Switzerland, Netherlands, Germany, Portugal, Italy, Greece, and Turkey directly reporting to him. Additionally, he has successfully coordinated global QA/RA projects with an extended on-site presence in the 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 his 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.