Regulatory Essentials in Health Tech

”I have more than twenty years of experience in the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).

My responsibilities have also spanned the design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of my career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”

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.