Regulatory Strategy and Market Access

After more than 20 years in the medical device industry—working across both manufacturing and consultancy—I started this company to share my experience where it can truly make a difference, with a focus on genuine, practical support.

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My career in regulatory affairs and quality assurance has taken me across a wide range of organizations—from agile start-ups and SMEs to large, multinational corporations—working across an equally broad spectrum of diagnostic and therapeutic areas and device types. This diverse experience has given me a well-rounded perspective on the practical challenges medical device companies face, particularly when it comes to finding reliable, cost-effective regulatory and quality support.

 

One key lesson I’ve learned is that no two companies or products are the same. Off-the-shelf, templated solutions often miss the mark. The best outcomes come from truly listening—understanding not only the immediate technical requirements of a project but also the broader commercial goals and strategic priorities that drive it.

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That insight is what drives Penbran. I’m committed to offering a service that’s individualized, transparent, flexible and grounded in your specific needs. Whether you need short-term support or are looking for a long-term partnership, I aim to work within your budget and on your terms—with the ultimate goal of helping you build sustainable, independent success.