Jonathan C. Bretz, OT/L, MBA, RAC
President, RSQM Associates, LLC. Over 35 years medical device experience including Regulatory Affairs/Compliance, Submission experience [510(k), CE Technical Files, Health Canada], Quality Systems (QSR, ISO 13485), Risk Mitigation (ISO 14971), Regulatory Strategies, UDI/GTINs, Product Development, Marketing & Sales, Operations and Supply Chain Management. His background in Occupational Therapy and Ergonomics has given him valuable experience in Human Factors assessments. Contact Jon at Jbretz@rsqmassociates.com. |
Matthew King, BS
Over 25 years of professional experience in Quality Assurance, Regulatory Compliance. Extensive CAPA, complaint handling, MDR Vigilance and other Post Market Surveillance issue management. Contact Matt at Mking@rsqmassociates.com. |
David Ennen, MS
In more than thirty years of product development experience David has played many roles including: R&D management, program management, technical lead, software engineering, software architecture, system engineering, and real-time embedded system design. The majority of David’s experience has been in the medical device field so he is very familiar with the regulated development guidelines and design control compliance. David has recently consulted in ISO 14971 – Risk Management, IEC 60601, 61010, 62304 as well as assessed Technical Files and Design History Files, and has constructed submissions for numerous regulatory regions. David has experience in medical devices, life science devices as well as devices associated with low voltage directives. He holds a B.S. in Physics from the University of Cincinnati and an M.S. in Biomedical engineering from the University of Michigan. Contact David at Dennen@rsqmassociates.com. |
Kenneth LePage, BS
Senior engineering development leader with over 25 years experience in bringing leading edge technology products to market. Expertise in Life Cycle Management of Hardware and Software products. Extensive experience working with early stage and midsize startups as well as Fortune 100 companies. Successful in helping companies improve their ability to execute project-related services in order to support the organization in addition to project-specific development programs. Experienced Project Manager in Product Development and Regulatory areas. Industries served include Medical, Telecommunications, Data Storage Management, Aerospace and Commercial. Contact Ken at Klepage@rsqmassociates.com. |
Richard "Dick" O'Brien, MBA
A business consultant with 30 years experience working with life science companies addressing new products design and development and the marketing of medical device and related bio-pharma products. He has led functional teams to prepare new product introductions, secure clear focus and preemptive corporate identification, build supply channel relationships, develop strategic approaches, plans, systems and resources for growth in domestic US and offshore product manufacturing. Mr. O'Brien's work includes preparing Advisory Boards for operating and emerging companies entering new and mature markets. Mr.O’Brien is President/CEO, MDG (Medical Development Group) Boston, a volunteer, 400 member not-for-profit group of professionals participating in the medical device and related life sciences industries. Contact Richard at Robrien@rsqmassociates.com. |
Alan Oslan, MS, MBA
Over 30 years experience in medical device product development engineering and cross-functional team leadership. Successful product launches of capital equipment and sterile disposables at start-up and mature companies. Extensive electrical, electromechanical, and software designs to safety standards (EN60601-1 and associated standards). Capable of assessing new technologies for clinical requirements, market needs, regulatory paths, business risks, and funding. In addition, he has created and led Usability Studies and written 510(k) submissions. Contact Alan at Aoslan@rsqmassociates.com. |