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How to develop an MDR-ready software application?

This material will help you understand the requirements of the new Medical Device Regulation (MDR) in Europe that every medical software will face. Revolve Healthcare provides bespoke software development services that comply with ISO13485 and IEC62304.

How to check if the medical app is MDR-ready?

First, every developer of healthcare software needs to check under which category I-III (if any) their application falls. MDR compliance requires a suitable quality management system and the use of technologies that are GDPR-compliant. It is recommended to obtain ISO 13485 certification and follow appropriate guidelines like IEC 62304. So every company that plans to develop an MDR-compliant software needs to make sure the technology they develop is MDR-proof.

The checklist below addresses some of the most important questions:

1. Under which category the software falls? (What is the Intended purpose of the application?).

2. Does it cover data pseudonymization?

3. Does it provide record-level encryption?

4. Does it provide a legally valid audit trail?

5. Does it properly cover user consent management?

In order for the software to be compliant with the MDR, the answers to questions 2-5 have to be YES.

How can Revolve Healthcare help?

Revolve Healthcare is a software engineering company that specialises in the creation of medical software. The offering covers all aspects of software engineering from design, development, deployment and maintenance. Revolve follows the best development practices to maintain the high quality necessary to comply with both ISO13485 and IEC 62304.