Our company is one of the few software houses which has a certified Quality Management System in accordance to ISO 13485:2016 and ISO 9001:2015.

As such, we are the ideal software partner/supplier for the design, development and servicing (post-release activities) of software that is used either as part of a medical product or as standalone alone medical product, and targets the MDR/IVDR and FDA market.

Our software development approach complies with the requirements of IEC 62304, including usability engineering processes (IEC 62366) and risk management (ISO 14971).

Repado is able to develop medical software which falls under IEC 62304 safety classes A, B and C.

Certification & Compliance

Below is a list of key standards/norms that our Quality System covers:

ISO 13485

Medical devices
Quality Management System


ISO 9001

Quality Management System


21 CFR Part 820

Quality System Regulation (FDA)


IEC 62304

Medical device software
safety classes A to C


ISO 14971

Risk management


IEC 62366-1

Usability engineering


IEC 82304

Health software



General Principle of
Software Validation