Quality & Compliance

Design and manufacturing procedures are controlled to ensure that we remain compliant with 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 well maintained throughout the entire product lifecycle management.

We have established procedures and detailed documentation to ensure total control throughout all stages of the product development cycle. We operate a diligent quality system that fulfill ISO 13485 and are FDA, Japan JPAL, Hong Kong Medical Device Control Office registered.