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Regulatory Essentials in Health Tech: The Core of the Regulatory Requirements

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This session introduces the General Safety and Performance Requirements, which are the heart of the regulation. It explains the principles of Clinical Evaluation and Risk Management for medical devices, both essential for fulfilling the manufacturer’s obligations.

The Regulatory Essentials in Health Tech training series comprises 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

Topics of this session

  • General Safety and Performance Requirements for Medical Devices
    • The heart of the regulation
  • Introduction to Clinical Evaluation
    • Related guidelines and standards, MEDDEV 2.7/1 and ISO 14155
    • Literature Reviews
    • Clinical Investigations
    • Post-Market Clinical Follow-up
    • Balancing between the necessary and the business advantage
  • Introduction to Risk Management
    • The ISO 14971 standard for Risk Management
    • The sequence of events and Risk Analysis
    • FMEA as the model for Risk Management
    • Risk mitigation
    • Benefit-Risk conclusions – balance with Clinical Evaluation


Karri Airola
Karri Airola
Senior 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.”

Target group

All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of health tech innovations and to avoid typical dead-ends due to non-compliance to the medical device or in vitro diagnostic regulations. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, business advisors, and investors from early seed development to international scaling.

After this session, you

  • Understand the core concepts of Clinical Evaluation, Risk Management, and the Benefit-Risk ratio to achieve and maintain the safety and efficacy of health technology.
  • Know which steps to take in product development to fulfill the General Safety and Performance Requirements.


Combining this on-demand session with the Regulatory Essentials sessions 1, 2, and 4 is recommended.

Billing and cancellation policy

Read the billing and cancellation policy for online trainings here.

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:  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: 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.

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