Regulatory Essentials in Health Tech – Session 6: Medical Device Software


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 such topics as artificial intelligence (AI) and cybersecurity are discussed.

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


 

SPRING 2022
Time: 5.4.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 15.9.2022
Place: Online
Price: 250€ + VAT 24%

 

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. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

After this session, you:
Know the specific regulatory requirements for developing safe and efficient medical device software.

Notice:
It is recommended to follow the Regulatory Essentials sessions 1-4 prior to this course. For more specific knowledge and hands-on approach to medical device software development it is recommended to follow the one-day SOFTWARE REQUIREMENTS COURSE.

Trainers:


Heikki:
 ”I have more than 20 years of experience from 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.
I´m the CEO and founder of Lean Entries Ltd, which is a part of the Labquality family of companies. Lean Entries provides the Entries platform with digital regulatory runway services, as well as training on the regulatory essentials, to organisations from health tech startups and universities to multinational manufacturers.”


Ilona:
”I have worked in regulatory compliance positions for 15 years. Prior to stepping into the Medical Device field, I held responsibilities in consumer electronics and environmental and material compliance and continue to advise manufacturers on those topics. For the past seven years, I have been guiding various health tech companies with Medical Device regulations. My experience ranges from the compliance of artificial intelligence (AI) medical software to hands-on clinical evaluation, and from setting up and auditing ISO 13485 compliant quality management systems to enabling the international market access for several types of health technology.”

CONTENT OF THIS SESSION:

    • Software Qualification and Classification
      • The EU perspective – the MDCG 2019-11 guidance document
      • Why do all software land in class IIa or higher in 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

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