US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach

Juan M Campos

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$349


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This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach.

Why Should You Attend:

Companies conducting business in various geographical regions have to address numerous specific regulatory requirements from each of those geographies. This webinar will provide practical tools to address specific requirements from US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements from an unique Quality Management System (QMS) architecture ensuring compliance with those regulations.

The webinar will discuss in detail how to address the gaps between US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements for:

  • Management responsibilities
  • Device marketing authorization
  • Facility registration
  • Measurement, analysis & improvement
  • Adverse events & vigilance reporting
  • Design and development
  • Manufacturing and service controls
  • Purchasing activities

Areas Covered in the Webinar:

  • Management responsibilities
  • Device marketing authorization
  • Facility registration
  • Measurement, analysis & improvement
  • Adverse events & vigilance reporting
  • Design and development
  • Manufacturing and service controls
  • Purchasing activities

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

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: 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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