Quality & ISO 13485

Quality in design & development

We are ISO 13485:2016 Quality Management for Medical Devices certified by BSI.

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

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.

To read our Quality Policy or view our ISO 13485 Certification please click on the link buttons below. For any enquires about quality or regulatory please e-mail: qualityandregulatory@osteoweld.health.