About RegYOU
With extensive experience in regulatory compliance for medical devices and a solid clinical background, RegYOU Consulting brings a unique blend of expertise to the table. RegYOU Consulting provides strategic guidance and expert support in areas such as regulatory strategy, product development, clinical evaluation, technical documentation, and post-market surveillance of medical devices.
If you are seeking a consultant with a proven track record in regulatory compliance expertise, enthusiasm, coaching style and a results-driven mindset, RegYOU Consulting is here to support your success.
RegYOU Story
My journey into regulatory compliance began with a deep curiosity about how scientific innovation translates into life-enhancing solutions. From my early PhD research at KU Leuven on oxidative stress markers in the human body to my experiences in the pharmaceutical and medical device industries, I learned that regulations, such as the EU Medical Device Regulation, are essential for ensuring a high level of safety and public health. This realization sparked my passion for the medical device sector, where I discovered that regulatory compliance is not merely about meeting standards but about fostering trust, protecting patients, and driving progress in healthcare. Over the years, I’ve had the privilege of collaborating with organizations to achieve CE marking of their medical devices and registrations approvals, guiding them through the complex regulatory landscape.
My focus extends beyond technicalities; I believe that every successful project can be accomplished when expertise and passion align. With this mindset, I have set-up my own company, RegYOUlatory Consulting, with a full commitment in helping partners and customers in this complex regulatory landscape and ensuring that their innovations in developing and supporting medical devices make a meaningful difference in the lives of patients and/or of the intended users.
Experience
Regulatory and clinical expertise: Over 20 years of experience in the Health Tech industry, including roles in global companies and as a senior RAQA consultant, with a strong reputation for providing trusted guidance on regulatory legislation, including the EU Medical Device Regulation (MDR) and other regional legislations, to ensure successful market introduction of medical devices.
Comprehensive regulatory and clinical strategies: Expertise in developing regulatory and clinical strategies for medical device software products, AI medical device software, custom-made devices, in-house devices, active devices and both invasive (e.g., implantable) non-invasive devices, including classification, verification and validation testing, risk management (ISO 14971), and post-market surveillance (PMS). Proficient in writing and reviewing technical documentation and clinical evaluation reports, as well as supporting the setup and maintenance of design history files and device master records to ensure compliance with regulatory requirements .
Medical device working groups and EU MDR Tailored trainings: Actively participated in medical device working groups and served as the MDR project management lead, delivering tailored training within global organizations, health tech companies, and universities. Focused on providing actionable solutions that enhance compliance and operational efficiency through a strategic and pragmatic approach.
