NEW! Online-Certificate Course: Medical Software Specialist in English

Your career stepping stone into the world of medical software & applications!

On April 26, 2024 our practice-oriented course on all regulatory requirements for medical software and apps will start in a compact online course. This time the course language is ENGLISH!

With this recognized certificate you can prove your qualifications and competences in the field of medical software!

  • 5 modules = 5 days (9:00-16:30 – ONLINE)
  • Next start: April 26 – June 7, 2024
  • Conclusion with online-exam and certificate!


The use of software in medical devices or of software as a medical device offers a wide range of new possibilities for making diagnoses more accurate and designing therapies more efficiently. For example, it is much easier to link data for a diagnosis or to implement new treatment and diagnostic procedures.

Software intended for this purpose is thus also subject to the analogous regulatory requirements and standards that apply, for example, to ventilators or implants. However, classification in this regulatory framework is quite difficult, especially in the case of software, and is often a matter of interpretation. It often boils down to the so-called intended use.


This course introduces the world of regulatory terminology and explains why the intended use is fundamental from the outset for anyone developing software in the context of a diagnosis or therapy of disease. And why proper classification is as important as the product idea itself.

Our online Medical Software Specialist course will provide you with the step-by-step knowledge to navigate this complex environment. This includes sound know-how on the relevant laws, standards and regulations, as well as on how to integrate the software lifecycle into the quality management system and the risk management system.

The developers of software for or as medical device(s) are ultimately more than just software developers. They create software products which, in addition to a clinically proven benefit for patients, must not entail any unacceptable risk. They must therefore meet all legal requirements for medical devices.

Manufacturers of software for or as medical device(s) therefore need specialists who have sound technical knowledge on the one hand and competence in regulatory and clinical matters on the other. These specialists are in great demand! The medical device market is one of the most innovative and fastest growing markets in recent years.

Apply for our scholarship – 2 x € 490,-!


Module 1 Development of software for medical devices April 26, 2024 | 9am-4.30pm
Module 2 Implementation of IEC 62304 and IEC 82304-1 for medical device software manufacturers May 08, 2024 | 9am-4.30pm
Module 3 Risk management for medical device software – ISO 14971 May 24, 2024 | 9am-4.30pm
Module 4 UX and Usability for Medical Software and Apps – IEC 62366-1 June 03, 2024 | 9am-4.30pm
Module 5 Cybersecurity – IT security for medical devices June 07, 2024 | 9am-4.30pm

Single modules also available!

Online-Certificate-Course: Medical Software Specialist – Folder-Download here!


  • Medical device manufacturers whose products contain software or are software products in their own right, from the areas of regulatory affairs, quality management, systems and software engineering, usability engineering, requirements engineering, project management, risk management, product management, IT, management,
  • Service provider / supplier in the medical technology,
  • Consultants for medical software
  • Newcomer & Start-Ups


  • Early bird (until March 29, 2024): Euro 2.350,- (excl. VAT)
  • Standard (starting with March 30, 2024): Euro 2.590,- (excl. VAT)
  • incl. seminar documents as PDF and a certificate of participation
  • Installment payment on request!
  • Apply for our scholarship – 2 x € 490,-!


10% discount for

  • Cluster members (Standortagentur Tirol, Forum Medtech Pharma, Styria, LISAvienna, MTC Upper Austria, Innovation Salzburg Mitglieder)
  • from the 2nd participant of a company/organization
  • for returning visitors
  • The discounts cannot be combined.
  • All seminar discounts at a glance


The course concludes with an online exam (multiple choice) and an individual final discussion on the contents of all modules. After successfully passing the exam, you will receive your personal certificate.

With this recognized degree, you provide proof of qualification and competence in the field of medical-use software:

  • You have the necessary knowledge about the desired functions and any risks of software.
  • You are able to include the legal and normative foundations already during the software development process.
  • Your know-how ensures user-friendliness and risk minimization.


You only need a laptop with camera and microphone for the ONLINE modules. Our eLearning platform works on all operating systems in the web browser (eg Firefox, Safari or Chrome). You will receive the course documents as a PDF and the link to the virtual seminar room in good time by email. Each module will be designed interactively – 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!

If you have any questions, please do not hesitate to contact us:

Mag. (FH) Christa Bachinger-Hauk
Mail: or
phone: +43 1 8863491