Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Carolyn Guthrie serves as the Vice President of Regulatory Affairs and Quality Assurance for Kapstone Medical. She has been in the Medical Device industry in quality and regulatory functions for almost 20 years, working for and with both large corporations and start-up companies with a single employee. The types of devices she has worked with has varied from In Vitro Diagnostic devices to Orthopedic, Dental, Software, and Kitting, Packaging, & Sterilization devices. Carolyn has experience globally, with a focus on North America and Europe, in both the premarket and postmarket quality and regulatory functions, including premarket submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems. Originally from South Africa, Carolyn is now based out of South Florida. She holds a BS in Biochemistry and Microbiology and an MS in Human Cell Biology from the University of Cape Town in South Africa and an MS in Regulatory Affairs (International) from Northeastern University in Boston, MA. In addition, she holds a RAC (Regulatory Affairs Professional Society Certification) for the US.

Self-starting, strategic thinker recognized as a subject matter expert in Medical Device Quality Management Systems including Risk Management, Design and Development, Management Responsibilities and Improvement. Specific experience includes audit and submissions to comply with US QSR (21CFR820), ISO 13485, Canadian Medical Device Regulations (CMDR/CMDCAS), Medical Device Directive (MDD), In-vitro Diagnostic Directive (IVDD), Japan Pharmaceutical Affairs Law (JPAL), Therapeutic Goods Act (TGA), Brazilian regulations (ANVISA) including the Medical Device Single Audit Program (MDSAP). Extensive career experience throughout the product life cycle for all classes of medical devices and drug combination devices from concept through development to product release and post-market support. Solid reputation for maintaining a firm grasp of project details while also keeping the big picture in focus.

Quality Systems--
Quality Systems expert participating member with ISO TC210, WG1 on next revision of ISO13485. Recognized subject matter expert for Medical Device Product Risk Management (ISO 14971). Called on by senior management to integrate the quality systems of acquisitions and remediate notified body audit major non-conformance as well as provide direct support and auditor interface for numerous audit/inspections (including FDA, EU certification/notified bodies and other competent authorities (ANVISA, TGA, etc.).

Operations--
Served as the area quality assurance leader and a site mentor for the Corrective/Preventive Action (CAPA) program. Supervised all quality group responsibilities for facility electronics manufacturing area with several direct and indirect reports.

Design/Development--
Lead Design Assurance team member from concept through design development and into post market support for several next generation products and new product lines. Participated in supplier selection and led audits for supplier qualification.

Mark DuVal, J.D., is President & CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

Satyajit “Sat” Ketkar is the Director of Systems Engineering at Velentium. His 20+-year career includes electrical, firmware, software, and systems engineering experience, including seven in medical device design and two with a European Union-notified body conducting medical device reviews and audits for safety, quality, performance, and security. He holds a B.S. in Electrical & Computer Engineering and a MEng in Computer Engineering from the University of Houston.