Assembling a new quality management system from scratch is our specialty. No cookie-cutter solutions! We take the time to learn about your company, on or off-site, and customise our services to your specific requirements. We also help bigger organizations manufacture and smaller companies outsource manufacture. We convert non-medical QMS to medical and fill holes in current systems.
Also, Access-2-Healthcare was part of the TC210 teams actively developing and writing ISO13485 and ISO14971 standards, and has extensive expertise in medical technology production and commercial situations.