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MEDICAL DEVICES - QUALITY SYSTEMS ISO 13485
This webinar discusses key aspects of ISO 13485:2016: management responsibilities, document control, design & development, supplier management, manufacturing processes, and corrective & preventive actions amongst others.
Overview of the webinar
Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.
Who should attend?
- Quality and Regulatory Directors and Managers
- Design & Development Directors and Managers
- Operations Directors and Managers
Why should you attend?
Webinar attendees will understand and be able to ensure compliance with ISO 13485:2016 requirements related to management responsibilities, document control, design & development, supplier management, manufacturing processes, and corrective & preventive actions amongst others.
Faculty - Mr.Juan M. Campos
Juan M. Campos is a Medical Device professional with + 37 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 Regulation, 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 + 37 years 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, an active project evaluation expert at the BioExpert Network as well as an Accredited Assessor of the Acció program for life sciences.