Medical Devices – EU Medical Device Regulation 2017/745
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Speaker : JUAN M. CAMPOS
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When : Tuesday, January 14, 2025
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Time : 01 : 00 PM EST
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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.
This webinar discusses key aspects of MDR: device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI and EUDAMED.
Areas Covered
This webinar discusses key aspects of MDR: device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI and EUDAMED.
Who Should Attend
Quality and Regulatory Directors and Managers, Design and Development Directors and Managers.
Why Should You Attend
Webinar attendees will understand and be able to ensure compliance with MDR requirements related to device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI, and EUDAMED.
Topic Background
Compliance with European Medical Device Regulation 2017/745 (MDR) is mandatory for all medical devices placed in the market in any member state of the European Union. It is of strategic importance for any medical device manufacturer to understand and effectively apply the MDR requirements to access this critical market.
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$199.00
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