Join Greenlight Guru, Velentium, Galen Data, and Minneapolis's top medical device quality, regulatory, clinical data, and engineering professionals for learning, networking, drinks, and hors d'oeuvres.
A panel of seasoned medical device professionals will discuss the top challenges, strategies, and opportunities in the medical device industry in 2023 and beyond. They'll share how product development, regulatory, and quality management can address and adapt to the future.
Plus, ask the experts live questions following the discussion!
Join Etienne Nichols as he sits down with Howard Root, former CEO and co-founder of Vascular Solutions and Author of Cardiac Arrest, and Mark Duval, President and CEO of DuVal & Associates, P.A.
MedTech professionals are invited to attend and enjoy our specially selected drinks and hors d'oeuvres.
Your city's top medtech leaders, quality, regulatory, clinical data, & engineering professionals are invited to attend the event to network and enjoy our specialty drinks and hor d'oeuvres.
A panel of seasoned medical device professionals will share their personal industry stories, experiences, key takeaways, and thoughts on the recent 2023 MedTech Industry Benchmark Report.
Experience a live recording of the Global Medical Device Podcast where Etienne Nichols sits down with some of the best minds in Medtech to get actionable insider knowledge.
The Greenlight Guru True Quality Roadshow brings together MedTech leaders in quality, regulatory, clinical, and product development to learn industry best practices and trends, meet their local MedTech community, and find inspiration to continue improving the quality of life.
Interested in joining them? There's still some sponsorship options available. Learn more here.
We are working to finalize the rest of the speakers, if you would like to join them, let us know!
Medical Device Guru | Greenlight Guru
Medical Device Guru | Greenlight Guru
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.
Former Founder and CEO of Vascular Solutions & Author
Former Founder and CEO of Vascular Solutions & Author
Howard Root is the retired Chief Executive Officer of Vascular Solutions, Inc., a company he founded in 1997, took public in 2000 and grew into a worldwide medical device company that he sold to Teleflex in February 2017 for $1 billion. Over the company’s 20 years, Howard led Vascular Solutions in inventing, developing and launching over 100 new medical devices used to improve the lives of patients suffering from cardiovascular disease. The motivation behind the sale of Vascular Solutions and Howard’s voluntary early retirement is a true-life legal nightmare that is detailed in Howard’s book: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds’ Hit-List.
VP of Regulatory Affairs & Quality Assurance at Kapstone Medical
VP of Regulatory Affairs & Quality Assurance at Kapstone Medical
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.
Partner | QRx Partners
Partner | QRx Partners
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.
President | DuVal & Associates, PA
President | DuVal & Associates, PA
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.
Director of Systems Engineering | Velentium
Director of Systems Engineering | Velentium
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.