Gwilym Owen
Senior Consultant, Global Regulatory Consulting
Expertise:
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 Device Directive (MDD). The structure of the MDD allowed for broad and varied interpretations of the Directive, and some SaMD manufacturers relied upon this leeway to self-classify devices as low-risk Class I. Now, with the MDR in effect, these devices are stuck in a loophole and face serious challenges in meeting the rigors of the […]
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 medical devices are developed and regulated. Many new regulations and policies were introduced or issued after years in the making, and others were reactions to sweeping technological and methodological industry advancements that required broad changes in the global regulatory environment. First, we’ll zoom in on key global initiatives poised to shake up digital health. Then, […]