Thomson Software Solutions achieves ISO 13485

CASE STUDY: Thomson Software Solutions

Thomson Software Solutions achieves ISO 13485 with Compliant.

Why Thomson Software Solutions decided to invest in ISO 13485

ISO standard 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Software producer Thomson Software Solutions has successfully achieved ISO 13485 with Compliant.

The UK based business produces software for optometrists and eye hospitals.

Professor David Thomson, founder of Thomson Software Solutions explained that “the products that we produce must be UKCA marked to be sold in the United Kingdom and CE marked for sales in Europe. To achieve this, companies must demonstrate that they have a quality management system in place.

The ISO 13485 standard is specifically designed for companies that produce medical devices; making it the ideal standard for us to implement.”

The Process

David went onto explain “We started from scratch with ISO 13485. It would have taken us a very long time to create an appropriate quality management system on our own. Compliant provided all of the templates needed for the certification and we were able to customise them to meet our requirements.

We now have our starter pack in place which has already been successfully audited. We now need to fully integrate our new quality management system into our processes and will be working with Compliant to ensure that our staff are familiar with the system and to keep the management system up to date.”

Having ISO 13485 in place ensures the products that Thomson Software Solutions are delivering are safe, effective, and delivered to a high standard. The ISO 13485 standard is the most accepted global standard of its kind and working with Compliant makes sure that Thomson Software Solutions is up to speed with national and global requirements for its industry.

The Outcome

When asked about the experience with Compliant David highlighted that “Mark was always very helpful, responsive and available. He offered a lot of handholding on the run up to and during the audit.”

Compliant Director Mark Henderson commented “Here at Compliant we are always excited about exploring new industries and new certifications. ISO 13485 has been a great certification for us to add to our offering and implementing this standard with David and Thomson Software Solutions has been great. Well done to David and the team for getting started with ISO 13485, we are looking forward to working with the team and helping to embed the management system going forward.”