Pamela Gwynn has dedicated her 36-year career at UL Solutions to advancing health and safety standards for medical and personal health devices. As a principal engineer with Consumer, Medical and Information Technologies (CMIT), she collaborates with manufacturers to navigate complex challenges in market access testing, certification and standards compliance. Pamela’s expertise spans writing standards, addressing emerging product categories and driving innovations that make life-saving technologies accessible and reliable worldwide. Her work includes leadership in the US national and international electrotechnical standards and in the International Electrotechnical Commission (IEC) Committee for Testing Laboratories and chairing medical-focused task forces, where she helps shape international standards that strengthen product quality across borders.
Market access: Testing and certification
Pamela provides technical insights for colleagues facing uncommon compliance questions and collaborates with customers on new product requirements, helping them meet evolving regulatory demands. She plays a vital role in helping ensure that medical devices and healthcare products meet stringent safety and performance standards, facilitating smoother global market access for manufacturers. By overseeing testing and certification processes within UL Solutions, she helps enable medical products tested in one country to be accepted in others under the IEC System for Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE) Certification Body (CB) Scheme.
Her work not only helps companies streamline compliance but also supports the rapid deployment of safer, innovative health technologies worldwide. As chair of the Committee for Testing Laboratories, Pamela champions consistent, high-quality assessments that bolster trust and reliability in certified products, ultimately enhancing public health and safety on a global scale.
International safety standards development
With over three decades at UL Solutions, she not only contributes to standard development and technical guidance but also plays a prominent role in the international standards community. She brings thought leadership and direction across testing labs globally, ensuring mutual recognition of testing reports and consistent adherence to harmonized standards. Her commitment to these efforts strengthens and promotes global safety and reliability in medical device applications.
“I am passionate about collaborating with innovators who push the boundaries of healthcare and safety. Together, we create solutions that help ensure that essential technologies reach the market safely and effectively.” - Pamela Gwynn
Panels and boards
- Panelist contributor. Wearable Technology – Regulatory and Standards Consideration. TechTextile. 2017.
- Presenter. What to expect with Amendment 2 of IEC 60601-1 and related collaterals. IEEE Symposium of Product Compliance Engineering. 2020.
- Panelist. Japan IAS FDA ASCA Event. 2021.
- Presenter. Regulations and Concerns for Wearable Devices – Understanding on the possible safety and performance issues. ISPCE. 2022.
- Panelist and presenter. Solutions for Medical Device Companies. U.S.-German Standards Panel, Washington, D,C. 2016.
- Panel contributor and presenter. Wearable Technology – Regulatory and Standards Consideration. NC State University. 2016.
- Co-convenor, IECEE Committee of Testing Laboratories (CTL) – ETF 3.
- Board member, Association for Advancement of Medical Instrumentation (AAMI) Standards
ES – Electrical Safety Committee
EV/WG 12 – Luminaires Working Group
U.S. TAG 62D – Electrical Equipment Committee
RB – Robotics Committee - FDA ASCA program manager
- Chair, NFPA 99 Health Care Facilities Code – Medical Equipment (HEA-MED)
- Chair, NFPA 99 Health Care Facilities Code – Electrical Systems (HEA-ELS)
- Member, NFPA 70, Code Making Panel 15
- Co-chair, AAMI Committee MP
- AAMI Robotics Committee
- Member, IEC Technical Committee (TC) 61 – PT 60335-2-115 – Beauty Appliances
- Member, IEC TC 61 – MT16 Biological effects of optical radiation
- Member, IEC TC 62 WG 4 – Terminology – Convenor
- Member, TC 62 - /AC 1 – Electrical equipment in medical practice
- Member, TC 62/SC 62A/JWG 6, Medical electrical equipment and systems for use in home care applications
- Member, TC 62/SC 62 A/JWG 8, Medical electrical equipment and systems for use in the emergency medical services environment
- Member, TC 62/SC 62 A/JWG 9, Medical electrical equipment and systems for use in the emergency medical services environment TC 62/SC 62A/MT 28, Electrical hazards
- Member, TC 62/SC 62A/MT 30, Overheating, fire protection and additional hazards
- Member, TC 62/SC 62A/PT 62353, Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
- Member, TC 62/SC 62A/PT 62354, General testing procedures for medical electrical equipment
- Member, TC 62/SC 62A/WG 14, Testing to General Safety Standard
- Member, TC 62/SC 62A/WG 20, Environmental Protection
- Member, TC 62/SC 62D/JWG 22, Electromedical diagnostic and patient monitoring equipment
- Member, TC 62/SC62D/JWG36 – Medical Robots for Rehabilitation
- Member, TC 62/AhG 36, Alignment on the approach regarding “refurbishment” standards including the interpretation of “refurbishment” and “life cycle”
- Member, TC 62/SC 62A/PT 62A-1, Essential Performance Fault safety
Press
- “The New Paradigm for Medical Device Safety; Addressing the Requirements of IEC 60601-1 Edition 3.1.” UL Solutions. 2015.
- “Rebuilt Medical Equipment and Systems.” UL Solutions. 2015.
- “Home Healthcare Equipment: An Overview.” UL Solutions. 2023.
- “The Safety of Personal Hygiene and Beauty Therapy Equipment Used in Commercial Settings.” UL Solutions. 2012.
- “Testing Your Patience.” Orthopedic Design and Technology. 2017.
