OsteoWeld is recommended for ISO 13485 certification

We are pleased to announce that we have been recommended for ISO 13485:2016 Medical Device Quality Management System certification by BSI!

As a small pre-revenue medical device start-up we have hugely ambitious goals, and achieving this recommendation certification has been one of the biggest!

We began our quality journey in September 2021 when we were successfully awarded an Innovate UK Smart Award to develop our next generation ultrasonic-enabled SutureWeld polymer implant for surgical knot replacement.

Ensuring that our development processes follow the ISO 13485 standard right from the start of the regulatory pathway means that we will be bringing state-of-the-art products to the market, with patient and user safety and usability requirements being paramount.

Put simply: the Quality Management System is the foundation on which all of our future regulatory technical files and product approval applications will be based on. It is a major milestone along our commercialisation timeline.

Thank you to our employees and business partners who have been critical to the success of this fantastic achievement!