Hello! I’m Irene YAP, a former chemist who traded the laboratory for the world of regulatory affairs, specializing in EU MDR compliance. My path into the world of regulatory affairs began in an unexpected way. When I first entered the medical device industry seven years ago, I had zero experience with the intricacies of CE marking or the regulatory requirements in the European Union. My background was in chemistry, and I previously worked in the pharmaceutical industry, testing drugs, functional foods, and cosmetics. I then transitioned into a new role as a writer for a medical device company. Despite my lack of experience, the leader of the small manufacturing company saw potential in me and took a chance. It was a bold move for both of us, but it set me on a path that changed everything. 

I was thrown into the deep end, entrusted with establishing technical files to secure CE marking for all products in the entire company's portfolio. The learning curve was steep. We faced numerous non-conformities - not the major ones that could sink a project, but enough to keep me on my toes. It took a lot of determination, late nights, and frankly, sweat and tears to navigate through the complexities. Each challenge became a learning opportunity, and over time, I learned to think ahead, anticipate concerns from the notified body, and develop solutions that would prevent problems before they arose. When we obtained the CE mark, the sense of satisfaction I felt was beyond words. I remain grateful to this day for someone who took a chance on me, believed in my potential, and ultimately changed the course of my path. 

Through that experience, I gained a deep understanding of regulatory requirements and how to navigate them efficiently. I learned to prevent the issues that had previously cost us significant time and effort. What once felt like an uphill battle became second nature, and I now use that expertise to help other medical device manufacturers avoid similar struggles. 

Today, building on my experience from numerous audits of diverse device types, including active medical devices with software, sterile surgical instruments and more, I apply this knowledge to guide my clients through the complexities of the EU MDR. I specialize in helping them develop robust technical documentation, navigate regulatory challenges with ease, and attain CE marking with confidence. 

If you're interested in embarking on this regulatory journey together, feel free to contact me today to get started or simply send a message to find out more.

Warm regards,

IreneYap

Writer/Consultant