Regulatory Essentials in Health Tech
Regulatory Essentials in Health Tech
Topics of this session
Terhi HeikkinenQuality & Regulatory Affairs Manager
Mika SiitonenBusiness Development Manager
Heikki PitkänenCEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
Karri AirolaSenior Expert, Regulations, Quality & Training
”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.”
Harinder KorhonenQuality & Regulatory Affairs Manager
Leena RaunioQuality and Regulatory Affairs Manager
Hanna MarttilaManager, Clinical Studies
Jouni KarkinenCEO, Karkinen Consulting
Kirsten SanderARTIMED, Clinical Research Team Lead
We highly recommend this training series to any health tech stakeholder for gaining crucial knowledge on regulatory requirements. Health tech start-ups and university innovator teams, as well as new recruits and experienced medical device professionals throughout the field, are warmly welcome.
All attendees are granted free and unlimited access to Entries, the Digital Regulatory Runways and training recordings for the duration of six months. Every individual will also get certificates of attendance according to the sessions attended. Please note: the entire training series is held in English.
After this session, you
Will save months’ worth of work in reaching the market.
The Regulatory Essentials in Health Tech training series is tailored to turn regulatory compliance into a business advantage for health tech companies and to avoid the typical pitfalls of the sector.
The training series is complemented with Entries, the Digital Regulatory Runway service, to navigate the basic regulatory requirements in a matter of minutes.
Notice1900 € for the full training series of 14 sessions (250 € for one individual session). Three or more attendees from the same organisation are entitled to a 20 % reduction for the full training series. Incubators and regional business units, as well as universities and other institutions, may request unlimited access for their start-ups or researcher teams, students and staff for 7500€/year. (Prices are VAT 0%). Contact email@example.com for group discounts and institutional registrations.
Billing and cancellation policy
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.
Cancellations are always made in writing to: firstname.lastname@example.org.
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: email@example.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event. Labquality reserves the right to cancel the training session due to a small number of participants.