The trainer is Karri Airola, Quality and Regulatory Affairs Manager, Aurevia Oy

Karri Airola has over 20 years of experience in the medical device industry in a variety of specialist, responsible, and leadership roles. He has worked in several companies, being responsible, among other things, for manufacturers’ quality systems as well as the compliance of the medical devices they develop and manufacture with ISO 13485, EU MDR, IVDR, US FDA, ANVISA (Brazil), and TGA (Australia) requirements.

Airola’s experience covers the entire product lifecycle, from the design and development of new products to the practical implementation of quality systems for both traditional medical devices and software-based products. He has also worked with intellectual property rights (IPR), supply chain management, and strategic aspects related to market access. In addition, Airola has been involved in startup companies both as a co-founder and in various responsible roles, supporting product development and commercialization in international markets.

Airola has gained specific expertise during his career in medical software, implantable devices, and products in orthopedics and dentistry. This expertise is complemented by a strong background in biomaterials, polymers, and the application of biocompatibility requirements in accordance with the ISO 10993 standard series. In addition, he has experience in clinical evaluation for both implantable and non-implantable medical devices, as well as for IVD devices and IVDR requirements through consulting projects carried out for IVD companies.