We proudly inform that senior regulatory affairs expert Merja Vainio is our new medical device specialist, strengthening Medfiles’ regulatory affairs service offering.


Merja Vainio has worked for 20 years in medical device and in vitro diagnostic industries and has a profound expertise in MD and IVD regulations, risk management and quality management systems. Over the years, she has developed and productised several medical devices and in vitro diagnostic tests from a product idea to post-market surveillance actions, using the best practices to fulfil the regulatory and quality requirements. She is also highly experienced on developing and maintaining the ISO 13485 based quality management system.

Merja and our MD & IVD team are at your disposal if you have questions or training needs related to quality management systems, MD or IVD requirements.

Our valued effort is to serve clients in a practical, co-operative and customer-focused way.
Please do not hesitate to contact us for additional information.

[one-half-first] Päivi Turta
Regulatory Affairs Manager
tel. +358 50 313 0323
[/one-half-first] [one-half] Merja Vainio
Senior Regulatory Affairs Expert
tel. +358 40 504 0213

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