Medical Device Quality Systems – International Approach: Iso 13486:2016 & Mdsap

The subject of the webinar covers the main medical device quality system regulations required for international markets outside of the US like Europe, Canada, Brazil, Australia, and Japan.

Key Learning Objectives of the topic understand the medical device quality system regulations for ISO 13485:2016 and countries under the MDSAP regulation outside the US (Europe, Canada, Brazil, Japan, and Australia).

ISO 13485:2016

• Quality Management Systems
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis, and improvement

MDSAP (Medical Devices Single Audit Program)

• Management
• Device marketing authorization & device registration
• Measuring, analysis, and improvement
• Adverse events and recalls
• Design and development
• Purchasing

The webinar will provide the key medical device quality system elements that the US medical device companies will need to comply with to successfully plan and execute their international expansion plans in key markets like Europe, Canada, Brazil, Japan, and Australia.

The target audience will be the Quality, Regulatory and Manufacturing/Operations Managers/Directors from US medical device industries.

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.