Work smarter,
and stay audit-ready.

We use TraceX to manage our Quality Management System. The platform is clear, structured, and perfectly suited to the requirements of a regulated environment. It allows us to centralize our quality processes and ensure reliable traceability of actions, documents, and non-conformities, while remaining easy to use. The time savings are real, and our overall visibility of the QMS has significantly improved.

TraceX has done an incredible job developing an all encompassing software for development teams, providing the whole array of management services from project planning and team management to an FDA/MDR compliant eQMS infrastructure. The TraceX team has built a great community to engage directly with their end users, providing prompt technical support and fostering an open dialogue to receive feedback and help guide future software development.

I use TraceX to manage our quality management system, and we’ve saved a lot of time on document review and approval. The traceability and organization of documents are clear, and the ability to send questionnaires to the teams allows us to easily validate knowledge! I highly recommend it 👍.

We're really enjoying building our QMS in TraceX - highlights for us are the features to create and track training documents, and generally the ability to organise document creation and review in an intuitive and scalable way.

After years of seeing manufacturers manage their quality management systems with Word and Excel files that are difficult to maintain, or with complex and expensive eQMS solutions, we discovered with TraceX a solution that is particularly well suited for medical device companies.

At CSDmed, we have deployed it with several of our clients as part of implementing quality management systems compliant with ISO 13485 and MDR requirements.

The platform enables teams to efficiently structure documentation, manage quality processes, and maintain clear traceability, while remaining easy for teams to adopt and use.

The feedback from the manufacturers we support has been very positive.

As a MedTech Quality and Regulatory consultant at BioQMS, it’s essential for me to have a range of eQMS tools available to meet the diverse needs of my clients because a one-size-fits-all approach simply doesn’t work.

I often recommend TraceX to startup clients, particularly those with distributed teams who may feel an electronic Quality Management System is out of reach. As an entry-level solution, TraceX is intuitive, accessible, and a significant improvement over paper-based systems.

Being a QARA professional means mastering complex medical device regulations… and then struggling to find the right tools to actually apply them. At least, that was the case before TraceX.

Today, everything is different. TraceX brings it all together, a single platform to govern them all, centralizing our quality system without compromising on compliance.

Where we once needed five different tools to meet five different requirements, TraceX now does it all in one place. And that changes everything.

As part of our ISO 13485 certification, we were introduced to TraceX by our consulting firm CSDmed. This turned out to be a great discovery and a real asset in setting up our regulatory documentation.

TraceX has enabled significant progress and simplified our record-keeping processes. In addition, the availability and responsiveness of their team are a real advantage for an SME like CIR Medical.

What truly sets TraceX apart is their strong commitment to listening to user needs and continuously improving the platform.

The TraceX Team is highly responsive, open to feedback, and genuinely invested in building features that align with the real challenges faced by Quality Assurance teams. Rather than offering a static solution, they actively collaborate with us to refine and evolve the product over time.

This level of engagement and adaptability makes TraceX a valuable partner for any medtech looking to implement a practical and evolving eQMS.

TraceX is a very strong solution for MedTech startups:

The platform is powerful, the modules are built with real domain expertise, and everything remains aligned with the financial constraints of an early-stage company.