ISO 13485 – QMS Compliance, Consulting & Implementation

Why Work With Us

We have built multiple quality management systems from scratch, successfully passed external audits, and completed CE certifications.

We build QMS processes that primarily work for your organisation; compliance is essential, but the internal processes must work for the team first.

We are not afraid of making deep cuts into non-functioning systems to bring quality management back on track.

We will build modern, digitised and understandable Quality Management Systems.

To whom does ISO 13485 apply?

Compliance with ISO 13485 applies to manufacturers and developers of medical device software and connected medical devices. This includes organisations developing standalone medical software, as well as those incorporating software into hardware devices, particularly those operating in regulated markets like the EU, the U.S., and other jurisdictions.

Quality management systems are essential for ensuring the safety, efficacy, and quality of medical devices. Compliance with ISO 13485 ensures that medical device software meets internationally recognised quality standards, safeguarding users and meeting regulatory obligations.

Compliance requirements for ISO 13485 are linked to broader regulatory frameworks, such as the implementation of EU MDR/IVDR (2017/745), which emphasise quality management as part of medical device compliance, or the FDA's quality system regulation, which outlines expectations for medical devices in the U.S.