EU MDR 2017/745 Custom Made Medical Devices

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.