Twin Cities Chapter In Person Event: MN Medical Devices Essentials 2026

Jackie Torfin

CEO & Principal Advisor, QLeaR Advisors

Jacqueline Torfin is the CEO and Principal Advisor of QLeaR Advisors, where she empowers MedTech and Biotech companies to conquer quality and regulatory challenges. With over 36 years of experience, she translates a complex web of global regulations into actionable strategies for start-ups and emerging growth companies. Her distinguished corporate career includes executive global roles in quality, regulatory, and clinical affairs for major firms like Beckman Coulter, PDL BioPharma, 3M/Arizant, Heraeus, and NAMSA, where she led quality, compliance, data protection, and program management offices. A dedicated advocate for the profession, Ms. Torfin also serves as adjunct faculty at St. Cloud State University, where she helped design and now teaches in the Master’s program for Medical Technology Quality and Regulatory Affairs. She is a certified Quality Auditor (ASQ) and an ISO 9001/13485 and EU MDR certified auditor for Europe. Ms. Torfin holds a B.S. in Medical Technology from the University of Minnesota and an M.A. in Leadership from Augsburg College.

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Aaron Hage JD, RAC

VP, Legal-Regulatory & Compliance, DuVal & Associates

Aaron Hage, JD, RAC, is Vice President of Legal-Regulatory and Compliance at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Aaron has a wide range of regulatory experience including Medical Device Reporting, Corrective Action/Preventive Action (CAPA), 510(k) submissions, PMA supplements, technical file reviews, advertising/promotional reviews, notified body audits, and FDA inspections. Aaron earned his Juris Doctor from William Mitchell College of Law and his Bachelor of Science in Microbiology from the University of Minnesota - Twin Cities. Aaron holds a Regulatory Affairs Certificate (RAC) from RAPS and is also registered to practice before the United States Patent and Trademark Office.

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James Kleinedler PhD

Director, Regulatory Strategy, Medtronic

Jim Kleinedler, Ph.D., is Director of Regulatory Strategy at Medtronic, supporting innovative programs across the product lifecycle. Previously at Boston Scientific, he led IDE, 510(k), and PMA submissions and engaged regulators on early feasibility, IRB/EC, and breakthrough designations in interventional cardiology. He also served as an FDA reviewer of Class II/III cardiovascular devices and biocompatibility focal point within CDRH. Dr. Kleinedler holds a B.S. in Chemical Engineering (Iowa State) and a Ph.D. in Toxicology (LSU). He has authored over a dozen peer-reviewed publications, holds seven patents, and teaches in St. Cloud State’s graduate regulatory affairs program.

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Rob Allen

Senior Director, Regulatory Affairs & Biocompatibility, MCRA, an IQVIA Business

Rob Allen leads a team supporting medical device manufacturers in biocompatibility, chemical characterization, and toxicological risk assessment at MCRA. Prior to joining MCRA, Rob served as an FDA reviewer in the Center for Devices and Radiological Health, where he led and conducted biocompatibility reviews for cardiovascular devices.

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Lindsey K. Borton

M.P.H., DABT, Principal , Gradient

Lindsey Borton is a toxicologist and engineer with 10+ years of industry experience in medical device biological safety and risk assessment. At Gradient, Ms. Borton develops strategies for the biological safety assessment of medical devices in support of European, US FDA, and other worldwide medical device regulations. She also performs toxicological risk assessments of extractable and leachable compounds for human health risk assessment. She holds an M.P.H. in Regulatory Toxicology and Risk Assessment from the University of Minnesota (2016), a B.S. in Biomedical Engineering magna cum laude from Michigan Technological University (2010), and is a Diplomate of the American Board of Toxicology (DABT).

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Cheryl Marker Ph.D.

DABT , Canyon Labs

Cheryl Marker is a board certified (DABT) toxicologist and currently serves as a toxicology consultant at Canyon Labs. Dr. Marker has over 17 years of experience in the medical device and pharmaceutical industry. Currently, Dr. Marker focuses on the non-clinical toxicology aspects of medical device development including absorbable/degradable devices, preparing toxicological risk assessments, (TRAs) biological assessment plans (BEPs) and reports (BERs), as well as device change assessment plans and reports. Prior to joining Canyon Labs, Dr. Marker was a Study Director at several Contract Research Organizations (CROs) where she gained extensive experience overseeing a wide variety of study types including toxicology, pharmacology, biocompatibility, medical device, and interventional/surgical studies. While a Study Director, Dr. Marker specialized in developing custom models to assess unique challenges for both medical device and pharmaceutical testing. Cheryl earned her BS in Chemical Engineering with an emphasis in Biochemical Engineering from the University of Minnesota. She earned her PhD in Pharmacology with an emphasis in Neuroscience from the University of Minnesota Medical School.

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William Wustenberg

President and Senior Consultant , Mycroft Medical

Dr. William Wustenberg has been an independent biomaterials toxicology and medical device biological safety consultant for medical device companies around the world for over 27 years.  He particularly likes working on complex projects that require an understanding beyond the biomaterial safety issues and processes.  Consulting for over 1000 companies to date, he has overseen more than a thousand devices through the design and approval processes for the US Food and Drug Administration (FDA), the Conformité Européenne (CE) Notified Bodies, Canada, Australia and other venues around the world.

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Amra Racic

VP of Global Government Strategy , Veeva MedTech

Amra Racic is the Vice President of Global Government Strategy for MedTech at Veeva Systems, bringing over 25 years of healthcare experience and nearly two decades spent at the forefront of the medical device industry. Her career spans an impressive arc from patient care management to global regulatory leadership, grounded in a genuine passion for improving patient outcomes and advancing health equity through innovation.

Before joining Veeva, Amra built her regulatory expertise across some of the industry's most respected organizations, including Abbott and Bayer. She spent 13 years at Medtronic, where she led global regulatory advocacy, strategy, and intelligence initiatives that positioned the organization at the center of industry-wide policy conversations. Throughout that tenure, she represented Medtronic in numerous external working groups and held chair, co-chair, and subject matter expert roles that shaped regulatory thinking across the sector.

Amra's work sits at the intersection of technology, regulation, and health equity, and she remains a compelling voice on how MedTech innovation can and should serve all patients.

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Minori Carlsson

Divisional Vice President of Regulatory Affairs , Abbott

Minori Carlsson is the Divisional Vice President of Regulatory Affairs at Abbott, a role she stepped into in 2025 following a career defined by progressive regulatory leadership across some of MedTech's most influential organizations.

Minori spent over 17 years at Medtronic, rising from Regulatory Affairs Specialist to Senior Regulatory Affairs Director. That tenure gave her deep roots in both domestic and international regulatory strategy, including six years leading international regulatory affairs and nearly five years at the senior director level overseeing complex, high-stakes submissions and organizational regulatory functions across the Minneapolis headquarters.

She then joined Philips as Head of Regulatory Affairs, where she led the regulatory function for more than three years before bringing her breadth of experience to Abbott. With over two decades in the field, Minori's career reflects a steady commitment to building regulatory infrastructure that keeps pace with an evolving device landscape.

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Divya Rahman

Senior Director QARA, Strategic Affairs and Program Governance , Teleflex

Divya Raman, JD, MS, PMP, is the Sr Director of QARA Strategic Affairs and Program Governance at Teleflex Inc. In this role Divya leads quality and regulatory programs for M&A, divestitures, and other strategic priorities, and oversees the intelligence and policy program. Divya is well-versed in the area of program management and regulatory affairs and is passionate about how those two functions effectively support medical device lifecycle management. Divya has over 13 years of experience in the medical device field in multiple functional areas, such as technical communication, regulatory affairs, and medical affairs, and 6 years of experience in the legal field.

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Emily Hilstrom

Senior Regulatory Affairs Manager , Medtronic

Emily Hilstrom is a Senior Regulatory Affairs Manager at Medtronic with more than 14 years of experience leading global regulatory strategy for Class II–III medical devices across the UE, EU, and international markets. She has held progressively senior roles spanning post‑market, pre‑market, and regulatory leadership.

A central focus of Emily’s work is reimagining how regulatory affairs operates in a global, AI‑enabled future. She is passionate about applying artificial intelligence and hyperautomation to accelerate time to market, improve global consistency, and enable regulatory teams to move beyond manual execution toward strategic leadership. Emily believes AI will be a critical enabler in scaling regulatory expertise and responsibly bringing innovative technologies to patients faster.  She also believes this evolution requires leaders who invest in people, foster learning, and create space for teams to bring ideas forward, experiment, improve, and grow together.

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Lisa Pritchard BSEEE, FRAPS

VP of Regulatory, Quality, Clinical & Engineering , DuVal & Associates, P.A.

Lisa Pritchard, BSEEE, FRAPS, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., a law firm dedicated to counseling companies primarily in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics for medical devices including in vitro diagnostics, assisting clients with worldwide regulatory strategies, and FDA submissions such as pre-submissions, IDEs, 510(k)s, De Novos, and PMAs. Lisa currently serves as Chair of the Twin Cities Chapter for the Regulatory Affairs Professionals Society (RAPS). She is an active volunteer mentor and sought after international speaker on regulatory topics. Lisa brings over 35 years of experience in working with industry including start-up companies, multi-national corporations, and now consulting.

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Kathy Herzog BSME

Sr. Regulatory, Quality, and Compliance Associate, DuVal & Associates, PA

Kathy Herzog, BSME, is senior director, regulatory, quality, and compliance at DuVal & Associates, PA. She has worked in the medical device industry for over 30 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class II and class III products in the orthopedic, neuromodulation, urological, and wound dressing therapeutic areas. She is experienced with US marketing submissions (pre-submissions, IDEs, 510(k)s, De Novos, breakthrough device designation requests, emergency yse authorizations, HUDs/HDES, PMAs and PMA supplements). She also assists clients with quality system, SOP, and labeling development.

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Nancy Cameron

Combination Products Lead , Medtronic

Nancy Cameron, MS, RAC, CQA, is a chemist with over 30 years of experience in the regulated medical device and pharmaceutical industries.  Her expertise is in analytical method development and validation, preparing and reviewing regulatory submissions for devices, pharmaceuticals, and combination products, including CMC sections for US combination product submissions and drug consultation dossiers for Europe.  Nancy is a Distinguished Regulatory Affairs Advisor supporting Medtronic's Cardiac Rhythm Management (CRM) products and an adjunct instructor co-teaching the Combination Products, Drugs & Biologics course in the MS in Regulatory Science Program at the University of St. Thomas.

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Angie Riascos

Director of Regulatory Affairs , Abbott, Structural Heart Division

Angie Riascos is Director of Regulatory Affairs for Abbott's structural heart division, responsible for leading the global regulatory strategy for the company's transcatheter mitral and tricuspid valve repair and replacement portfolio. With over 15 years of experience in regulatory affairs in the medical device industry, Angie has successfully shaped strategies that drive access to new and existing technologies globally. Prior to Abbott, she held roles of increasing responsibility at 3M and Medtronic, where she led and supported regulatory activities throughout the product lifecycle. Angie holds a Bachelor of Science degree in Industrial Engineering from Universidad Autonoma in Colombia.

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April Young PhD

President & CEO , Causeway Medtech, LLC

April Young joined the FDA under the prestigious Presidential Management Fellowship program. Based in Minneapolis, she served as a Consumer Safety Officer focused on drugs, devices, and dietary supplements, and became the district drug specialist conducting audits that led to several compliance actions. After the FDA, April led quality and regulatory teams across companies ranging from startups to large global organizations. She founded Causeway Medtech in 2023 and now works with medical device and pharma companies on development projects, submissions, audits, compliance cases, and remediation.

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Adam True

Customer Specialist Manager, TÜV SÜD America

Adam True is a Customer Specialist Manager with TÜV SÜD America, Inc., bringing more than 15 years of experience in the pharmaceutical and medical device industries and over four years working with notified bodies and regulatory agencies. He specializes in quality and regulatory compliance, as well as quality assurance and quality control for pharmaceutical and medical device manufacturing.

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Tom Brumbaugh

Medical Device Testing Manager , TÜV SÜD America

Tom Brumbaugh is the Medical Device Testing Manager for TÜV SÜD America. With more than eight years at TÜV SÜD, his career spans EMC and wireless testing, electrical safety, project management, and business development. Tom combines a strong technical foundation in Materials Science and engineering compliance with hands‑on experience supporting medical device manufacturers through complex testing and regulatory pathways. His passion lies in partnering with companies to efficiently bring safe, compliant, high‑quality medical technologies to market.

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Susan Matthias

Consumer Safety Officer, U.S. Food and Drug Administration

Susan Matthias is a Consumer Safety Officer, Special Assistant in Office of Medical Device and Radiological Health Inspectorate (OMDRHI). She is responsible for assisting the office director with a wide variety of coordination and administrative projects, managing the OMDRHI strategic direction, and providing expertise as a subject matter expert. Prior to this position, she was a Device Specialist for eight years in OMDRHI’s central division, and maintains her Level II certification. She has worked for FDA since 2008. Prior to joining FDA, Ms. Matthias was the manufacturing manager for a mid-size medical device firm, where she managed production supervisors and manufacturing operations personnel. She also held various engineering and project management roles at industrial and automotive firms.

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Kristen Evenson

Senior Manager , Hyperfine, Inc.

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Angelina Lisandrelli

Director, Global Regulatory, Advertising and Promotion , Intuitive Surgical

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