Quality & Compliance

Detailed design procedures and controls ensure that we remain compliant with the requirements of ISO 13485 and FDA 21 CFR 820. Each new product design journey starts with a sketch and finishes with an approved Technical File that is maintained throughout the product life cycle.

We have established procedures and detailed documentation to ensure total control throughout all stages of the product development cycle. We operate a rigorous quality system approved to ISO 13485 and are FDA, Japan JPAL, Hong Kong Medical Device Control Office registered. These approvals allow us to brand our products with the worldwide recognised ‘CE’ mark, as prescribed in the Medical Device Directive, 93/42/EEC.