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Regulatory Essentials in Health Tech: Medical Device Software

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This session is dedicated to Medical Device Software, presenting the essentials of software qualification and classification from both the EU and US perspectives. The most relevant standards, IEC 62304 and IEC 82304, for Software Life Cycle requirements are introduced, and topics such as artificial intelligence (AI) and cybersecurity are discussed.

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

Topics of this session

  • Software Qualification and Classification
    • The EU perspective – the MDCG 2019-11 guidance document
    • Why does all software land in class IIa or higher in the EU, requiring a Notified Body?
    • The US FDA perspective
    • Unregulated software in hospitals – What to take into account?
  • Software Life Cycle requirements – Stand-alone and embedded SW
    • Software standards (IEC 62304 and IEC 82304-1)
    • Software safety classification according to IEC 62304
    • Medical software development and maintenance
    • Agile development from medical software point of view
    • AI/ML software in healthcare, regulatory aspects


Mika Siitonen
Mika Siitonen
Head of Digital Health
Mika is a business-orientated expert in software-driven medical devices and product registrations with over 15 years of experience in project management, R&D, and testing from the medical device field as well as other industries. He has a broad understanding of design control, testing methodology and its development, data visualization and statistical analysis. In his duties, Mika has specialized in software registrations and the new medical device regulation on software products.

Target group

All developers of medical software and stakeholders interested in gaining specific knowledge on what to take into account for the efficient commercialization of medical device software. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, and new employees.

After this session, you

Know the specific regulatory requirements for developing safe and efficient medical device software.


Following the Regulatory Essentials sessions 1-4 before this on-demand session 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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