Medical Devices


Compliance of medical device software

Workshop and materials will be in English language.

In order to prove the conformity of a programmable active medical device according to medical directives, it is necessary to provide compliant software, which must be safe and effective.

In the case of software as a stand-alone medical device, or as part of an active medical device, the standard requirements of EN 62304 shall be used to demonstrate its compliance, and the organization shall have an ISO 13485 quality management system in place.

Participants become familiar with the requirements of medical directives in relation to medical software, and through practical examples, they address compliance with software compliance requirements.


  • Brief description of the requirements of medical directives
  • Classification of the product as a medical device
  • Defining conformity requirements for the product
  • Ways to demonstrate the compliance of medical software
  • Descriptions of software as a medical device
  • Integration of medical software management processes into the quality management system
  • Demonstration of compliance with the requirements of the standards and expected documentation
  • An overview of the most important points in software development from the point of view of medical directives – practical examples

Rok Hrovatin PhD started assessing the risk of medical devices only a few years before Slovenia’s accession to the EU. The transposition of European directives has established requirements in this area with the Medical Devices Directive (MDD 93/42 / EEC). He gained experience and knowledge as the head of the testing laboratory for medical devices at SIQ, and soon after that also as a leading auditor in the field of medical devices and as a lecturer in this field.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.
Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Who should attend this workshop?

  • Manufacturers of medical software that is either a stand-alone medical device or an integral part of a PEMS (Programmable Electrical Medical System)
  • Representatives of medical software suppliers
  • Management representatives
  • All who want to acquire or upgrade their knowledge about providing or. demonstrating the compliance of medical software