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Who am I?
I'm Gwilym Owen, a Welshman and Regulatory Affairs and Quality Assurance professional with over 20 years of international experience in the medical device industry, spanning diagnostic, therapeutic, and software-based (SaMD) products. Throughout my career, I've led the development and implementation of RA/QA strategies, successfully navigated global regulatory approvals, and built quality systems aligned with ISO and regulatory standards.
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I bring deep knowledge of FDA pathways—including pre-subs, 510(k), and Q-Submissions—as well as EU MDR and key standards like ISO 13485, ISO 14971, IEC 62304, and IEC 82304. I've worked closely with both the FDA and EU Notified Bodies and have managed regulatory submissions for markets around the world, including the U.S., EU, UK, Canada, Japan, Korea, Australia, Brazil, Turkey and many more.
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I’ve worked across a wide range of diagnostic and therapeutic medical devices in multiple clinical areas—including oncology, neurology, maternal and neonatal health, orthodontics, and electrosurgery. My particular focus is on Software as a Medical Device (SaMD), especially diagnostic software deployed across various platforms such as mobile apps, PACS, server-based systems, and cloud environments. I also have hands-on experience with AI/ML-enabled technologies in this space.
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I’ve helped build regulatory and quality systems from the ground up for startups, scaled QMS frameworks for growing companies, and navigated the complexities of global compliance within large organizations. Whether it's setting up an agile, ISO-compliant QMS or aligning with corporate systems across regions, I’m comfortable working at any stage of a company’s growth.
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My experience spans a broad mix of device types—both software and hardware—including SaMD, CBT mobile apps, electrosurgical devices, dental devices, nasal sprays, pathology-related products, and photo biomodulation devices, among others.
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I’m passionate about bridging the gap between innovation and compliance, and helping teams deliver safe, effective, and high-quality products to patients globally.
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What Makes Penbran Different?
What you see is what you get...
Penbran is just me—so when we work together, you’re working directly with someone who brings over 20 years of hands-on experience. There’s no handoff to junior staff; you get my full attention, insight, and support throughout our collaboration.
Size and scale...
Penbran is a solo endeavor — no investors, no shareholders, and no team to manage (unless you count my kids). That gives me the freedom to be practical and flexible with pricing, without the pressure of overhead or corporate targets.
Transparency...
I bring a lot of experience to the table, but I know there’s always more to learn, especially since the global regulatory and quality landscape is constantly evolving. If there’s something outside my expertise or if you could benefit from more specialized support to ensure success, I’ll be upfront and let you know.
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For very specific tasks like statistical analysis or literature reviews, I may bring in third parties, but I’ll always get your approval first. Any direct costs associated with this will be passed on to you at cost, with no mark-up.
Clarity and control...
I know cost control is key, so I’ll keep you in the loop on both projected and actual costs, making it easy to see how current expenses stack up against the budget. I’ll also be clear about how certain any information or recommendations are, along with the potential risks, so you can make informed decisions that align with your priorities.
Flexibility...
Depending on your budget and needs, I can set up contracts that work best for you. This might include fixed-rate projects, phased work with individual budgets, or just on-demand support and advice, with time and budget limits as needed.
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Whether you need me to be hands-on and embedded in the project team, providing strategic advice and reviews, working independently, or a mix of all three, I’ll work closely with you to adapt to your needs and the goals of the project.
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Since regulatory and quality projects can evolve over time, I stay flexible to changes in priorities or circumstances. My approach allows you to switch contract types as needed, ensuring everything stays aligned with where the project is heading.
Collaboration...
As a standard practice, I’ll always provide the reasoning behind my advice or work, explain the "why" behind conclusions, and walk you through the process so you can gain valuable insights from each project. I believe in sharing knowledge, not guarding it, and I’ll make every effort to pass that knowledge on to you.
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Depending on your needs and priorities, we can structure projects such that I work incrementally in close collaboration with you, so you or your team can gain as much experience as possible along the way.