Basic course: General regulatory requirements for software for or as a medical device

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Kalender
Tickets
Wann:
10. Oktober 2025 um 09:00 – 16:30
2025-10-10T09:00:00+02:00
2025-10-10T16:30:00+02:00
Wo:
ONLINE
Preis:
€ 610,-
Kontakt:
E-Mail
FH & Universitäten Gesundheitswesen IVD Medizintechnik Produktentwicklung Regulatory Affairs

This seminar will be held in English.

The development of standalone software such as mobile medical applications but also the integration of software as a component in medical devices means a complex challenge for many medical device manufacturers in the intersection of technology, regulations and clinical evidence.

In this seminar, you will gain an overview of the regulatory requirements in Europe and USA and familiarize yourself with the specifics of placing medical software on the market. The requirements for classification and conformity assessment procedures of medical software in the most important markets will be shown to you in a practical manner and using current examples.

PARTICIPANTS

This basic course is suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the legal framework for medical software development.

This basic course is part of our online course: Medical Software Specialist!

SEMINAR CONTENT

General regulatory requirements for medical software in Europe and USA

  • Overview of regulatory frameworks for medical software
  • Decision support for the classification of software as a medical device
  • Special features of standalone incl. mobile medical applications („APP“) and embedded software
  • Classification principles for medical software
  • Exercises:
    • How to use the digital health policy navigator (USA-FDA)
    • How to classify your medical software / app
    • General Safety and Performance Requirements (Template-Matrix)

YOUR TRAINER

  • Martin Schmid, Managing Director & Senior Consultant at en.co.tec Schmid KG

COSTS

  • Early bird (until 4 weeks before the seminar): Euro 540,- (excl. VAT)
  • Standard (starting 4 weeks before the seminar): Euro 610,- (excl. VAT)
  • incl. seminar documentation as PDF and confirmation of participation
  • Overview of all discounts

LOCATION: ONLINE

You only need a laptop with camera and microphone for our ONLINE seminars. Our eLearning platform works on all operating systems in the web browser (eg Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room in time by email. The seminar will be interactive – similar to a face-to-face seminar – i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.

Click here to book now!

For questions: office@encotec.at or +43 1 8863491