Regulatory Consultant

• Experienced regulatory professional and former U.S. FDA reviewer
• 10 years of experience in the medical device field
• Experienced in a broad range of medical device types, including women's health, obstetric/gynecologic, surgical, wound care, cardiovascular, and software devices

Dr. Monica Fahrenholtz earned her Ph.D. in Bioengineering from Rice University and began her career in academic medicine, supporting fetal and neonatal surgical research at Texas Children's Hospital/Baylor College of Medicine. During her tenure in the hospital's Department of Surgery, she helped secure over $19 million in funding and contributed to an Investigational Device Exemption (IDE) for a novel fetal surgery intervention, which was later FDA-approved.

Dr. Fahrenholtz then joined the Obstetrical and Reproductive Health Devices team (OHT3/DHT3B) in U.S. FDA's CDRH as a lead reviewer, where she reviewed and provided regulatory feedback and decisions on marketing submissions such as 510(k), De Novo, IDE, and Q-submissions, including STeP and Breakthrough designations.

In her current role as a regulatory consultant, Dr. Fahrenholtz applies her expertise in medical device regulation and scientific writing to guide medical device companies seeking marketing authorization in the U.S. Her services include regulatory and communications strategy and review and compilation marketing submissions, with specific expertise in women's health, obstetric/gynecologic, surgical, and software devices.

Senior Biocompatibility and Toxicology Consultant

• Medical device biocompatibility and toxicology subject matter expert
• 15+ years of experience in the medical device industry, with a career spanning both Contract Research Organization (CRO) with GLP test laboratories and global medical device manufacturers
• Experienced in a broad range of medical device types and combination products

Brandon Hahnlen has built a distinguished career in the medical device industry, serving in roles ranging from toxicology Lab Technologist to GLP Senior Study Director at NAMSA as well as Staff Toxicologist and Biocompatibility/Toxicology Senior Scientist at several global medical device manufacturers. His experience also includes analytical laboratory and GLP study director management.

Brandon has a strong foundation in the ISO 10993 series of standards and associated testing, including Chemical Characterization (E&L) studies, Toxicological Risk Assessment, in vitro biocompatibility with emphasis on genotoxicity testing, in vivo biocompatibility testing (both compendial and surgical methods), as well as hemocompatibility testing. With many years of GLP Study Director experience for a wide range of complex devices across sub-specialties, Brandon has assisted numerous clients navigate the requirements of biological safety standards including ISO 10993 series, ISO 18652, ISO 11979, and USP <1663>/<1664>.

Brandon's academic background includes a Bachelor of Science in Molecular and Cellular Biology with a minor in Chemistry from Kent State University, and an MBA from Bowling Green State University's Schmidthorst College of Business. His dual expertise in science and business enables him to bridge technical and strategic needs, making him a valuable asset in product development.

Principal Packaging Consultant

• Subject matter expert in packaging development, validation, remediation, and usability engineering
• Over 30 years of experience in the medical device and pharmaceutical industries, with a career spanning both consulting and global manufacturers
• Experienced in broad range of packaging solutions for medical devices, combination products, and pharmaceuticals

David DiVaccaro is a seasoned packaging expert with over 30 years of experience in the medical device and pharmaceutical industries. His career includes impactful roles at leading companies such as Edwards Lifesciences, Zimmer Biomet, Johnson & Johnson (DePuy Synthes and Cordis), Sanofi, Anika, Baxter, and various start-ups. Throughout his decades of experience, David has developed deep expertise in package design, process validation, machinery selection/replacement, package risk assessments, remediation, and supplier relationships.

He is a long-standing contributor to industry standards and education, recognized for his leadership, innovation, and commitment to advancing packaging practices. His innovative packaging designs have earned two Ameristar Awards, and he was honored with the 2025 Institute of Packaging Professionals (IoPP) Medical Device Packaging Technical Committee (MDPTC) Honor Award for his contributions to the field.

David has served as Ombudsman for the IoPP MDPTC for over 14 years and is a contributing author to several key industry publications, including all three editions of The Medical Device Validation Handbook, Medical Device Packaging, and the upcoming Medical Device Packaging Handbook, 3rd Edition. He has shared his insights as a speaker and panelist at major packaging conferences such as HealthPack and thePACKout, and has been featured in industry media including ORTHOWORLD and BONEZONE.

A long-term member of IoPP, David is also a former VP and co-founder of the South Florida Chapter, and a past member of the Drug & Pharmaceutical Packaging Committee. He is also an active ASTM member, continuing to shape the future of medical packaging through collaboration and thought leadership. David is a 6-Sigma Certified Process Excellence Black Belt and holds both B.S. and M.S. degrees in Packaging from Michigan State University.

President Causeway MedTech LLC

• Former U.S. FDA expert auditor
• Previously led regulatory, marketing and quality compliance at several global manufacturers
• Over 15 years of experience in the regulated medical device and pharmaceutical fields

Dr. April Young brings over 15 years of regulatory and quality leadership to the medical device and pharmaceutical industries, anchored by her tenure as an expert auditor at the U.S. FDA. During her five years at the U.S. FDA, she led highly complex audits leading to enforcement actions such as Warning Letters, Seizures, and Injunctions for drugs, medical devices, bioresearch monitoring, and dietary supplements.

Following her U.S. FDA service, Dr. Young held senior roles in industry, including Director of Quality Compliance & Global Regulatory at Abbott Laboratories, where she led the EU MDR transition across their global medical device portfolio. She also previously served as Director of Quality, Regulatory & Marketing at Rx Function, where she oversaw all quality, regulatory, and marketing ad/promo activities from bench to commercial launch for a medical device product, including implementation of a Quality Management System. Prior, Dr. Young served as a Quality & Regulatory Program Manager at Wright Medical (now Stryker), another global medical device manufacturer.

Senior Microbiology & Sterilization Consultant

• Medical device microbiology, reprocessing, and sterilization subject matter expert
• Over 25 years of experience in the medical device industry, with a career spanning both global medical device manufacturers and a Contract Research Organization (CRO) with test laboratories
• Experienced in a broad range of medical device types, including complex surgical instruments and permanent implants

Julie Tuinstra is a distinguished sterilization and microbiology subject matter expert, bringing over 25 years of extensive experience in the medical device industry. Julie commenced her career at DePuy Synthes, a prominent global orthopaedic device manufacturer and a part of Johnson & Johnson, where she dedicated 16 years as a Scientist in Sterilization & Microbiology Sciences. During her tenure, she spearheaded sterilization validation initiatives, contributed to various new product development teams, supported product adoption assessments, conducted risk assessments for cleaning and sterilization processes, and developed standard operating procedures for sterility assurance and environmental monitoring programs. Her role provided her with in-depth laboratory experience in senior technical positions, enabling her to deliver practical, regulatory-focused solutions to challenges related to cleaning, disinfection, reprocessing and sterilization.

In 2015, Julie expanded her technical expertise as a Validation Consultant at NAMSA, a globally recognized Contract Research Organization. In this capacity, she showcased her technical leadership by formulating effective regulatory strategies that guided medical device manufacturers through the critical process of preparing their devices for market entry. Serving as both a technical and project lead on various cleaning, disinfection, and sterilization initiatives, she ensured that clients adhered to the U.S. and EU reprocessing and validation requirements. Her consulting responsibilities encompassed drafting validation protocols, overseeing laboratory testing and report preparation, reviewing Instructions For Use (IFUs) for regulatory compliance, leading sterilization validations for Gamma, Electron Beam, Steam and Ethylene Oxide, and developing sterility assurance standard operating procedures, including bioburden control, dose audits, bacterial endotoxin testing and environmental monitoring.

Julie next advanced her career by joining the team at KP Medical Device Consulting LLC as a Senior Sterilization & Microbiology Consultant. In this role, she collaborates closely with Dr. Katzenmeyer-Pleuss to support a diverse clientele ranging from emerging start-ups to established global medical device and pharmaceutical companies. Julie provides expert guidance on regulatory submissions related to cleaning, reprocessing and sterilization, crafting pre-market validation strategies, while efficiently addressing regulatory review deficiencies. Her expertise extends to designing and managing intricate microbiology and sterilization testing in partnership with third-party laboratories, leading protocol development, and execution through final summary reporting, and conducting IFU and risk assessments to assure compliance with U.S. and EU regulations. She is especially adept at synchronizing rigorous sterility assurance programs across various modalities – Gamma, Electron Beam, Steam and Ethylene Oxide – with clients' regulatory frameworks and market objectives.

Principal Consultant
Evera Regulatory Advisors

• 20 years of experience in the medical device regulatory field
• Experienced in a broad range of medical device types, including IVDs, with specific expertise in electromechanical devices used in cardiology and patient monitoring

Meaghan Bailey has nearly 20 years' experience developing regulatory strategies and submissions on behalf of device manufacturers seeking U.S. marketing authorization for their novel products. Her expertise includes the creation of effective regulatory pathways and submissions for Class II and III medical devices, providing regulatory input to cross-functional teams during product development, resolving U.S. FDA deficiencies, and preparing sponsors for U.S. FDA meetings. She has extensive experience working with electromechanical devices used in cardiology and patient monitoring.

Meaghan was previously an Executive Director at NSF International in their Medical Devices practice. Prior to that, she was a Managing Director at Becker & Associates Consulting, a boutique regulatory consulting firm in Washington, DC.

Meaghan holds a B.A. in Human Biology from University of Virginia and received her Regulatory Affairs Certification from RAPS.

Senior Biocompatibility and Toxicology Consultant

• Former U.S. FDA reviewer (contractor)
• Board-certified toxicologist (DABT) and laboratory animal technologist (LATG)
• 25 years of experience in the field of toxicology
• Experienced in a broad range of medical device types and combination products

Dr. Angela Burke is a board-certified toxicologist and laboratory animal technologist with extensive experience in biological safety and toxicological risk assessment. Throughout her career, Dr. Burke has held key roles at organizations such as LivaNova, NAMSA, and WIL Research Laboratories (now Charles River Laboratories), and has consulted for multiple firms including Tunnell Consulting and Actalent. She also worked as a toxicology subject matter expert (contractor) with the U.S. FDA to review biocompatibility and toxicology data in pre-market submissions for a wide variety of medical device types across the agency.

Dr. Burke's background includes hands-on experience as a Study Director for both GLP and non-GLP studies, including toxicology, genetic toxicology, immunotoxicity, analytical chemistry (e.g., extractables/leachables), microbiology, surgical and preclinical functional, and other specialized studies. Throughout her career, she has gained extensive knowledge of medical device regulations and biocompatibility/toxicology principles for assessment of risks to human health posed by chemicals, extractables, and leachables, including in silico and computational methodologies for toxicological risk assessment. Dr. Burke has deep understanding of ISO 10993-1, ISO 10993-18, ISO 10993-17 and other ISO 10993 series, ISO/TS 21726, ISO 18562, ISO 14971, GLP, GMP, OECD, EPA, USP, ANSI, AAMI as well as U.S. FDA, EU MDR, MHLW and other international requirements.

In her current role as a consultant, Dr. Burke's expertise lies in preclinical safety evaluation for medical devices and combination products, including biocompatibility and chemical characterization studies, toxicological and biological risk assessments, and pre-market submission support for U.S. FDA, EU MDR, and other international agencies. She is adept at interpreting complex toxicological data, performing literature reviews, and developing chemical profiles to ensure regulatory compliance and patient safety.

Dr. Burke earned her B.S. in Biology from Arkansas Tech University and her Ph.D. in Toxicology from the University of Arkansas for Medical Sciences, where she also completed postdoctoral research in vascular surgery. Her professional certifications include Diplomate of the American Board of Toxicology (DABT) and Laboratory Animal Technologist (LATG), and she is an active member of the Society of Toxicology.

Founder and Principal Consultant, Evera Regulatory Advisors

• Former U.S. FDA Branch Chief (Division of Orthopedic Devices; Division of Cardiovascular Devices) in the Center for Devices and Radiological Health (CDRH)
• Over 20 years of experience in the medical device and life sciences fields
• Experienced in a broad range of medical device types and combination products

Dr. Rhim brings over 20 years of experience in the medical device and life sciences field. Prior to founding Evera Regulatory Advisors, she served as the Global Business Lead for the North America medical device consulting team at NSF Health Sciences where she oversaw the regulatory, QMS, and audit workstreams. Dr. Rhim brings deep knowledge of medical device regulations from her time as a Branch Chief in the former Division of Orthopedic Devices and as a lead scientific reviewer in both the Division of Orthopedic Devices and Division of Cardiovascular Devices in the Center for Devices and Radiological Health (CDRH) at U.S. FDA. During her tenure at U.S. FDA, she was involved in streamlining the premarket and postmarket review process as well as the classification efforts for posterior cervical screw systems.

Dr. Rhim received her Ph.D. in Biomedical Engineering from Duke University and her B.S. and M.S. degrees in Materials Science and Engineering from M.I.T.