Revolve Healthcare

The week starts with important news.

Today, we are proud to announce the start of a new collaboration with MIV PSA.

MIV PSA is developing a specialised solution supporting TMJ diagnostics through advanced data analysis and visualisation. Such products demand not only clinical expertise, but also a mature approach to software lifecycle and quality.

Successful innovation happens when medical insight and software engineering evolve together. We are excited to begin working with the MIV PSA team and support the next phase of their product development.

Special thanks to Jakub Munk, CEO of MIV PSA, for the trust and open collaboration.

See how many healthcare projects we have delivered -> https://revolve.healthcare/projects

💬Traceability is the critical language regulatory specialists judge your product by.

From MDR and IVDR to FDA 21 CFR Part 820, ISO 13485, and IEC 62304 – every major framework in medical software development shares one word:
➡️ traceability.

Under MDR, notified bodies pay particular attention to the transparency of design decisions.
FDA 21 CFR 820 considers traceability a fundamental part of the quality management system.
ISO 14971 demands that risk control measures will be traceable from hazard identification to implementation and verification.

💡 In our latest article, we explore how traceability supports compliance with these standards. Check in the comments.