Marie Stutzmann

Marie Stutzmann

Senior Associate

Marie Stutzmann is a biomedical engineer with a specialization in regulatory affairs for medical devices. She has over 5 years of experience working in different medical device companies. She has been in charge of the redaction of clinical and biological evaluation reports, and also worked as a toxicological regulatory expert at a major French medical device company. In this role, she provided support during the design and development of various medical devices, including the evaluation of the impact of change on biological safety, redaction of toxicological risk assessments, and biological evaluation reports. At Medidee, Marie provides clients with strategic and assessment support related to the biological safety of medical devices, as well as any other request related to biocompatibility and biological requirements, covering the full product life cycle. Marie speaks fluently French and English, with extensive knowledge of German.


Bruno Strappa - Medidee Services

Bruno Strappa

Project Associate

Bruno holds a M. Sc. in Bioengineering. He manages a portfolio of regulatory compliance projects with both large bio-pharmaceutical firms and medical devices / IVD startups. He has previously worked at a medical device start-up managing an interdisciplinary team, developing the regulatory approach and related Technical Documentation. Bruno has extensive experience in the setup of regulatory strategies and related technical / QMS documentation for EU and US approval, especially for drug device combination and for IVD products where the concepts of scientific validity and analytical performance are central. Bruno is fluent in English and Spanish.


Paige Elizabeth Sutton - Medidee Services

Paige Elizabeth Sutton

Project Associate

Paige is a Quality Management and Regulatory professional with 10 years track record in the medical device industry. Her expertise includes product design and development, process validations, V&V, complaint handling, QC strategies, QMSdeployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced in maintaining QMS certification and FDA approvals for invasive and implantable products such as surgical spinal and orthopedic implant systems, products with neurological applications, and also textile products. Paige holds a BSc in Material Science and Engineering from Lehigh University (PA), is Lean Six Sigma Black Belt, and ASQ certified as a Certified Quality Engineer. Also, Paige is certified as a NAMSA Regulatory Toxicology specialist. Paige assists clients with product design and development of upper-classes medical devices, complex process control, and deployment/maintenance of QMS, including execution of audits and suppliers follow-up.


Stefan Staltmayr - Medidee Services

Stefan Staltmayr

Senior Associate

Stefan Staltmayr is an industrial engineer with an electrotechnical background and 9 years of experience within the international medical device industry. As a quality technician for production of medical devices he has gained strong knowledge of QMS according to EN ISO 13485. As one of the contact points for external audits (FDA, ISO, MDSAP, Inmetro) Stefan has experience in communicating with authorities / NBs. Beside the management of external audits Stefan acted as lead auditor for internal and supplier audits. As a product safety engineer for the product safety certification of active and non-active medical devices, Stefan has in-depth experience in preparation and execution of regulatory safety tests and approvals of medical devices and systems in cooperation with external accredited agencies and certification bodies. Due to his work as a product safety engineer Stefan has a profound understanding of IEC 60601 standard series, ISO 14971 risk management aspects, and on IECEE CB-schemes and NRTL test reports approach for medical devices. Stefan is fluent in German and English.