Lääkinnällisten laitteiden kliininen arviointi ja kliiniset laitetutkimukset

Terhi is a medical device professional with over 20 years of experience in product development, quality, and regulatory affairs as well as quality management system development. She has held responsibilities for building or improving QMS and technical documentation to enable QMS certification or product registration. Terhi has an extensive experience in project design control, risk management, verification and validation activities, CE and 510(k) submissions, and ISO 13485, EU MDR, EU IVDR, and FDA quality system requirements and their implementation.

Hanna Marttila is the Senior Advisor for Clinical Studies in Labquality's CRO business. She has over 25 years of experience in the life sciences sector, both in the public and private sectors. Hanna has strong expertise in clinical studies (drugs and medical devices) in both commercial and academic settings, where she has held various roles. Her work experience in regulatory roles related to medical devices and in drafting international marketing authorization applications has given her a comprehensive understanding of business practices and the application of laws and regulations.

Markus Vattulainen is a Data Manager in Labquality's CRO business. His responsibilities include designing clinical device research, modeling research data flows, server environments, data collection systems (ECRF), document management systems (TMF, ISF), programmatic controls for data quality, technical data security, and data protection for clinical research (GDPR).