Software has become an integral part of the world of medical devices. What do you need to bear in mind here?

Due to the “non-physical nature” of software, the intended purpose given by the manufacturer of the software is decisive in determining whether software is to be classified as medical device software (MDSW).

Although, strictly speaking, the EU regulations (MDR-IVDR) only refer to the intended purpose of finished products, it is essential, especially as a software manufacturer, to define the intended purpose as early as possible.

This makes it possible to influence the regulatory requirements resulting from the intended purpose at an early stage. On the other hand, the design and software development processes can already be carried out in accordance with the applicable regulatory requirements of the ordinances, if applicable.

Our tip: Define the intended purpose right at the start of product development and document it in writing. We will be happy to help you!

We also provide you with reliable support on your journey from development to market readiness for your medical device software (MDSW) or medical app and work with you to ensure that you comply with all relevant standards, guidelines and regulatory requirements.

Reference example: Diabetes app mySugr
To give you an idea of how the collaboration with en.co.tec works, we would like to show you an example here: We supported the Viennese startup mySugr with the ISO 13485 certification of a diabetes app and are still on hand as quality management support when another audit is due or other questions arise.

Our concrete offer:

  • Clarification of whether your software or app is a medical device.
  • Classification / Categorization / Software Safety classification
  • Implementation of all regulatory requirements:
    – Software life cycle process according to EN 62304
    – Quality management system according to ISO 13485
    – Risk management according to ISO 14971
  • Preparation & support for certification audits

Inquire now: office@encotec.at oder +43 1 8863491.

Further information