Standards, Harmonisation Process and Common Specifications

Nils-Åke has more than 35 years of experience in the medical device industry. He is based in Sweden as the CEO of QAdvis providing regulatory consultancy support and authorised representation to clients globally. He has deep international management experience of quality assurance and regulatory affairs as well as senior management positions within international Operations. Having also lived in the Middle East and the Far East he strives to explain and bridge different and sometimes cultural perspectives in the interpretation of standards and regulatory requirements.

Nils-Åke holds a Master of Science Electrical Engineering from Lund University. He is an active member of standard committee ISO TC210 for quality management system aspects, e.g. ISO 13485. Board member of EAAR and an active stakeholder member of EU COM MDCG working group for Standards.