Päivi TurtaRegulatory Affairs Manager, Medical Devices and In Vitro Diagnostics at Oy Medfiles Ltd
I have over 17 years’ experience on Quality Management of Medical Devices covering the whole life-time of the product. I worked for almost 15 years for a global IVD manufacturer of reagent, instrument and stand-alone software products. Nowadays I’m privileged to help several manufacturers as a representative of Oy Medfiles Ltd, one of the biggest and most experienced CROs in the Nordics and Baltics offering comprehensive services for medical device, pharmaceutical and food industries.
During the years, I have gained experience on several QMS processes including new product development, risk management, customer complaint and nonconformity management, vigilance and post-market surveillance. I have also worked with regulatory affairs related topics and I am consulting, auditing and training my customers on regulatory requirements and QMS. I have a master’s degree (technology) in Biotechnology from University of Turku, Finland.