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Regulatory Essentials in Health Tech: Compliance as a Business Advantage

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This session introduces the global regulatory landscape for medical devices and presents the areas health tech developers should focus on when bringing new innovations to the markets. Basic terminology, classification rules as well as the importance of a regulatory strategy and regulatory due diligence are presented.

The Regulatory Essentials in Health Tech training series consists of fourteen 2,5h webinar sessions.
Read more on the complete course page here.

Topics of this session

  • Global medical device regulations as your competitive advantage
  • Early focus of the health tech developer
    • Intended Purpose as the heart of your product
    • Is my product a medical device and what risk class? Software, hardware & borderlines
    • What does the risk class tell me about my path to market?
    • How to save resources and time? Avoid re-inventing regulatory compliance
    • Your Regulatory Strategy to market entry
  • Align compliance with your business, marketing and sales needs
    • General Safety and Performance Requirements as the heart of the regulation
    • Regulatory compliance in your Business Model and Value Proposition
    • The level of regulatory know-how in your business
    • Responsibilities and authorities within the business
    • Regulatory due diligence in investments, mergers & acquisitions – lessons learned


Heikki Pitkänen
Heikki Pitkänen
CEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
”I have more than 20 years of experience in the health tech field including responsibilities in product development as well as regulatory and quality-related positions. I have worked previously at SGS as a site manager providing Medical Device manufacturers with Notified Body, accredited test lab and training services for worldwide market access. I have participated in international standardization and in the CEN-CENELEC Advisory Board for Healthcare Standards."

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. Special 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

  • Have the know-how to apply the correct regulations and standards to your innovation
  • Understand the most crucial regulatory bottlenecks and typical pitfalls in the health tech business and time-to-market
  • Recognize the value of understanding the regulatory essentials from early on
  • Manage the basic terminology of the medical device regulations and standards


It is recommended to combine this session with the Regulatory Essentials sessions 2, 3 and 4.

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:  
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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