Thomas Casey – Consultant, Quality Systems and Regulatory Affairs.

Since 1986 Tom Casey has held numerous responsibilities within three device companies, and has served in consulting roles since 2012.  Tom has extensive experience with design controls and overall medical device product development, including successful commercial launch of approximately thirty medical devices and issuance of twenty six US device patents.  Detailed involvement and expertise in early stage (concept development), detailed device design, device verification/validation, design history file documentation, design transfer (to production), and routine commercial production.  Role responsibilities increased from individual contributor to team leader, and project manager to Vice President of R&D.  Tom served as both risk management subject matter expert and design control trainer while at Boston Scientific.  Tom’s long history with risk management has evolved from his early 1990’s adoption of FMEA’s to intimate familiarity with the today’s comprehensive risk management file.  This includes the direct linkage between risk and various Quality Management System elements, including design control.  Tom has developed and installed numerous risk based quality systems, including adjusting as necessary to evolving global expectations and standards.

Throughout the years Tom has held numerous production related responsibilities, including most recently the resolution of numerous regulatory issues within an aggressive timeline and without impacting ongoing production.  Tom’s roles have included concurrent process development (working alongside R&D), product transfer (acquisition related and internal restructuring), process validation/process controls (risk based), line support manufacturing engineer, line support quality engineer, quality control supervisor, and co-developer of self-directed work teams.  Additionally Tom held quality oversight responsibilities for seven international production facilities, and twenty six external manufacturing partners, as part of his Quality Leadership role within BSC-Endoscopy.

For the receipt and proper handling of incoming materials, product and components, Tom has utilized risk based approaches to identifying, employing and defending receiving acceptance activities.  This includes supplier classification, dock to stock, risk based inspections, physical testing and appropriate nonconformance activities.  Tom has developed and implemented several nonconforming product systems, with proper linkages to the underlying risk elements.  Tom’s experience also extends to overall handling and storage, as well as distribution controls, particularly their importance both on a daily basis as well as in the event of product failing to meet documented requirements.

Tom has experience in establishing equipment control systems, beginning with the identification of requirements through to demonstration that the requirements have been met.  Included in these efforts are the identification of both preventive maintenance and calibration requirements, as well as initiation of a system to track and document their proper completion.   Tom’s experience with identification and traceability extends into all facets of production, including as appropriate the systemic assignment of batch/lot/serial numbers and their recording within lot travelers/history records.  This also includes the performance of servicing activities as appropriate, both internally performed as well as through external partnerships.



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