This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
Why Should You Attend:
This 90-minute webinar is focused on understanding the Medical Device Single Audit Program (MDSAP), the scope of the program, how to apply, the authorized organizations, the rating system developed and what you can expect when signing onto the program. The webinar will discuss how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.
Highlights of the key regulatory requirements for medical devices will also be covered for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan.
Areas Covered in the Webinar:
Who Will Benefit:
This 90-minute webinar will provide invaluable assistance to all personnel in the medical device industry, who have a stake in expanding their business into a MDSAP participating country and for those interested in more information about MDSAP and how it may apply to them.
This webinar will be particularly useful for those involved in research and development, document creation for regulatory submission, data handling and for those conducting/monitoring/coordinating clinical investigation, performing risk management and post-market vigilance/surveillance. This webinar is a must for those who are looking to apply for a medical device registration and product license in a MDSAP country. Employees who will significantly benefit by attending this training include:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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.