Nils-Åke has over 30 years of experience in the Medical Device industry. He has long management experience of Quality Assurance and Regulatory Affairs but also senior management positions within production, technical services and development. Nils-Åke provides support for top management as well as line staff in a multitude of aspects to both large corporations and start-ups. It may be regulatory strategies or compliance projects on both local and corporate level.
He has in-depth experience from active relationship with Competent Authorities and the FDA in complex situations involving warning letter, import detention, adverse events, FSCA/recalls. He is responsible for the company’s European Authorised Representative services.
Nils-Åke holds a MSc in Electrical/Biomedical Engineering from Lund Institute of Technology. He is a member and participant of European Association of Authorised Representatives (EAAR) and in EU Commision MDCG working group for Standards. Active member in SIS/TK355, and international TC201/WG1 standard committee for Medical Quality Systems.
“How do you advise small and medium size MedTech companies to best navigate in sometimes troubled regulatory waters?” ”Increased authority focus on medical devices meeting state-of-the-art in standards and industry guidelines nowadays requires comprehensive and diverse regulatory competence. It is challenge for QA&RA professionals keep abreast of the current requirements. This fact should not be underestimated and need for external expertise should be planned. Clearly defined and understood, regulatory requirements up front will reduce the risk of delays of marketing introduction.”