OxDevice operates a Quality Management System certified by BSI to EN ISO 13485:2016. We are fully committed to best practice in medical design and development and operate a full-scope system including both design and manufacturing.
We operate a stage-gate design control system compliant with ISO 13485:2016 and FDA 21 CFR 820.30. The system has been refined over many years and is able to provide a fully comprehensive design history file to dovetail with your system.
The balance of benefit against risk is key with medical devices and risk management is embedded in the design and manufacturing processes at OxDevice. From high-level clinical hazard analyses through to design and process FMEAs, we provide well-documented solutions to reduce risk as far as possible.
From goods inwards to product dispatch, OxDevice manufacturing process are fully traceable. Everything we do is clearly documented in detailed work instructions and recorded in process records. Focussing on competence, our employees are fully trained to achieve excellent results and high production yields.
With many years of experience of providing regulatory consultancy services for class II and III medical devices, we can help you plan your regulatory strategy in the UK, EU, US and worldwide