Izi Bruker

Dr. Bruker has more than 25 years of experience in product development, quality and compliance, and regulatory and clinical affairs. His expertise encompasses compliance with US and EU regulations for medical devices and combination products, development of guidelines for evidence-based medicine, technology landscape analysis, strategic planning, due diligence, auditing, and project management.

Dr. Bruker is an experienced CGxP auditor for CMC, Clinical, and Laboratory, supporting products that contain devices, drugs or biologics. He has served as a member of Pharmacovigilance groups at Fortune 500 companies evaluating complaint and adverse event data for further action. Dr. Bruker has implemented and optimized R&D processes for medical device development in order to cut down the cycle time and increase productivity. He has designed and implemented design control processes in compliance with FDA and ISO requirements. He has been an advisor and trainer to large-cap pharmaceutical companies in combination product regulations, Quality System Regulation (QSR) and benefit-risk analysis. He has been a key member of the Quality Councils responsible for the operational integrity of the QSR and decisions on product recalls.

Dr. Bruker has written Clinical Evaluation Reports (CERs) in accordance with the latest EU medical device guidelines and participated in reviews and symposiums with Notified Bodies on the changes to EU regulations for medical devices. Dr. Bruker was a member of the Medical Device Innovation Consortium (MDIC), a collaborative effort between the US FDA and industry focused on Regulatory Science. In the orthopedic space, Dr. Bruker has designed and commercialized a multitude of products. He was a pioneer in the development of novel bio-resorbable polymer-based products in the sports medicine field in general and their application to joint preservation in particular.

He has collaborated with major teaching hospitals in the development of test methods and novel carrier systems for healing and regeneration. Dr. Bruker was a member of the Osteoarthritis Research Society International (OARSI) committee tasked by the FDA to critically evaluate the guidelines on “clinical development programs for the treatment and prevention of osteoarthritis.”

In the Ophthalmology space, Dr. Bruker has been involved in process development for contact lens manufacturing, intraocular lens design, testing, and development through commercialization. In general surgery, Dr. Bruker was involved in design and materials development for hernia repair, lung resection, and mesh development for pelvic organ prolapse.

Dr. Bruker holds a Ph.D., Chemical Engineering from the University of Wisconsin, Madison and a M.P.H., Comparative Effectiveness from Harvard School of Public Health. He received a B.S., Chemical Engineering from Rensselaer Polytechnic Institute and was named to the Whitney Gallery of Technical Achievers by GE Corporate R&D.