MDSAP and EU ISO 13485 Approach – US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW

The MDSAP (Medical Device Single Audit Program) applies to all medical device manufacturers, wherein a recognized Auditing Organization can perform a single audit to ensure that regulatory authorities are satisfied with the results of the audit performed as per the guidelines of the regulatory authorities participating in the program.

MDSAP allows a device manufacturer to be audited once for the five geographies currently been listed: Australia, Brazil, Canada, Japan and the United States. Companies conducting business within these geographical regions have to address numerous specific regulatory requirements from each of those geographies. This webinar will provide practical tools to address specific requirements and EU ISO 13485:2016 requirements from a unique Quality Management System (QMS) architecture ensuring compliance with those regulations.

Areas Covered in the Session :
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

Who Should Attend:

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


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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance