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A regulatory and quality affairs specialist with deep expertise in MDR compliance and international medical device regulations. Anne-Sophie supports companies in navigating complex regulatory landscapes, including FDA, Anvisa, Shonin, and CE marking requirements. She has extensive experience in post-market vigilance, complaint handling, and compliance for medical devices, with technical expertise in radioprotection, medical physics, and X-ray/MRI technologies. With a background in managing multicultural business environments, she is an expert in problem-solving, project management, and regulatory affairs strategy. 

A regulatory affairs consultant and ISO 13485 lead auditor specializing in in vitro diagnostic medical devices (IVD). Pieter advises IVD manufacturers entering the European market, pharma/biotech companies incorporating non-CE marked IVDs into clinical trials, and EU laboratories seeking IVDR compliance. His expertise includes regulatory strategy, quality management systems (ISO 13485 & IVDR), risk management, performance evaluation, and post-market surveillance. Pieter is the Co-Chair of the RAPS Belgium Local Networking Group and has extensive experience in clinical drug trials, both in hands-on and management roles. 

With a strong background in biomedical sciences and patent law, Emilie transitioned from research to patent engineering, specializing in life sciences. She advises startups, scale-ups, and established players on the competitive patent landscape, freedom-to-operate analyses, patentability of innovations, and opposition and nullity actions. Since 2021, she has been actively involved in drafting and prosecuting European and international patent applications, providing tailored IP strategies that empower clients to protect and commercialize their intellectual property assets

Stijn brings extensive expertise across biotechnology, pharmaceutical chemistry, plant protection products, fertilizers, and food and feed technologies. He is highly skilled in the drafting and prosecution of European and international patent applications and provides strategic advice on filing strategies, patentability assessments, and freedom-to-operate studies. With significant experience in due diligence, he excels at evaluating third-party patent portfolios and optimizing clients’ portfolios for due diligence evaluations. Stijn is also a seasoned advocate in opposition and appeal proceedings before the European Patent Office. Additionally, he is a recognized authority on Supplementary Protection Certificates (SPCs) for pharmaceuticals and agricultural products, qualified to represent clients before the Unitary Patent Office, and a registered Court Expert in Belgium for patent matters, including seizure procedures for suspected patent infringements.