Quality Assurance

quality assurance

We have installed quality systems for businesses of all sizes, in light and heavy industry, from internationally renowned multinationals to virtual companies and start ups. Regardless of size or industry, we have successfully registered them all with the chosen notified body. Following registration, we continue to advise our clients with as little or as much input as they require.

By taking an active role in our clients’ ongoing projects, undertaking internal audits, chairing management reviews and giving advice on labelling and instructions, we aim for thorough, consistent results.

Having done extensive business overseas, our expertise in regulatory and registration requirements stretches not only to European countries, but to the USA, Canada and the Middle East. We also automatically undertake the writing of CE technical files as a follow on from all our product development work.

ISO 13485

Recently, we undertook a project for a virtual company. By installing the ISO 13485 quality management system for them we built a company structure from using the framework of the standard.  This is now the model for the day to day working of this business, and is a good example of how effective a QMS can be in providing the required foundation for start up businesses.  We continue to provide QA/RA services as a part of this business and assist with its expansion.