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Gwilym Owen

Gwilym Owen

Senior Consultant, Global Regulatory Consulting


Consulting (Strategy Management & Regulatory), Digital Health, Digital Medicine, Medical Devices, Regulatory Compliance

Gwilym is a seasoned regulatory professional with 15+ years of experience in Software as a Medical Device (SaMD). His expertise spans startups to large corporations, covering manufacturers and distributors. Gwilym has contributed significantly to various diagnostic and therapeutic areas, including acute stroke, cancer, and liver fibrosis. Proficient in different platform types, he has authored submissions for global markets, including the US, EU, Turkey, Japan, Korea, Australia, Brazil, and Canada. Gwilym’s leadership in authoring pre-submissions, 510(k)s, and EU Technical Files for Class I, II, IIa, and IIb devices, along with his adept negotiation skills with EU notified bodies and FDA interactions, highlights his impact in the regulatory landscape. His commitment to ensuring compliance with industry standards, such as IEC 62304/82304 and ISO 14971, underscores his dedication to advancing medical device technologies globally.

Articles by Gwilym Owen

The Looming Legacy of Software as a Medical Device (SaMD) Misclassification Under Medical Device Directive (MDD)

Regulation (EU) 2017/745, the Medical Device Regulation (MDR), sent shockwaves through the industry with its stricter oversight and transparency demands. While the implementation challenges like delays, notified body capacity, and EUDAMED implementation have dominated discussions, a potentially bigger issue lurks for software as a medical device (SaMD) previously classified as Class I under the Medical […]

An Impactful Year for Global Regulation of Digital Health

2023 was a busy year with FDA and EU advancing key initiatives focused on AI/ML, cybersecurity, global harmonization, real-world evidence, and pharma companion apps…and more is coming in 2024. While 2023 brought its share of challenges for the digital health sector, it ultimately served as a pivotal year for shaping the future of how digital […]

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