Michael Rinck An independent consultant with over 30 years of international experience in developing and implementing corporate strategies in the areas of quality systems and regulatory compliance for the health care industry. He combines strong experience in quality, compliance and regulations with a pragmatic approach at both operational and strategic level. Specific expertise in production of sterile disposables, biocompatibility (ISO 10993) and clinical evaluation, quality systems and regulatory affairs for medical devices, API’s and pharmaceuticals. Experience in international supplier audits, implementation of complaint handling, medical device vigilance, CAPA and change control systems. Strong experience in validation projects for ETO sterilization (ISO 11135), sterilization with irradiation (ISO 11137) and chemical sterilization (ISO 14937). Project activities included definition of validation strategies, writing validation project protocols and reports, coordination of validation activities and external laboratory testing as well as coordination with Notified Bodies.
Long year international project activities in Europe, USA and Asia in regulatory processes for certification of innovative medical devices including new biomaterials, combination product and devices with animal tissue. Expertise in management of regulatory affairs projects in the EU, USA and Asia including product registration. Product experiences are available in the areas of active implantable medical devices, orthopaedic implants, absorbable biomaterials, extracorporeal systems and immuno-apheresis technologies, cardiovascular products, drug eluting stents, hemotherapy systems and IVD products as well as sterile parenteral solutions for dialysis and infusion.
Dr. Rinck is a regulatory specialist with strong scientific background in microbiology possessing a Diploma and a Ph.D. in Microbiology from Technical University Berlin and a License in Pharmacy. He has conducted research in antimicrobial coating, biomaterials and sterilization technologies and developed and implemented these into routine manufacturing processes. Special areas of interest are toxicological evaluations of biomaterials and extractables/leachables process validation such as sterilization and aseptic filling as well as writing and editing expert reports and clinical evaluation reports