‘We are passionate about what we do. Delivering value does not have to be at the expense of quality, or supporting our customers.’ Ji Hee Ko – Quality & Regulatory Affairs Manager
We recognise the importance of maintaining high standards in all that we do. We strive continually to meet all the standards expected of a responsible medical device supplier. Our quality ethos is embedded throughout our organisation and whether we are designing a new product, inspecting a newly manufactured component, or dispatching goods from our warehouse, we aim do so within the framework of our established quality system that complies with:
FDA 21 CFR PART 820; ISO 13485:2003, ISO 9001:2008 and the Medical Device Directive 93/42/EEC requirements.
Our quality and supply chain teams work with our partner organisations to ensure that our products meet all the agreed standards and specifications. A dedicated inspection team carries out a series of validations before the products are packed, sterilised and shipped to our customers.