Having a solid Quality Management System is the basis for all Regulatory Requirements, not only providing you a “presumption of conformity”, but invoking within your company a Quality Culture by following a set of instructions and requirements. This will also help you being on a leading edge among competitors from a market prospecting point of view.
ALPA Medical expertise can help you setting up a Quality System based on each or a combination of the below mentioned standards. We can write, review, audit, provide you with pragmatic ideas or simply helping you removing the unnecessary burden created by an heavy documentation system. We can also help you in specific sector of a Quality System, such as “CAPA”, “Non-Conforming Material”, “Documentation Control” etc…
our expertise
-CAN HELP YOU WITH THE FOLLOWING-
ISO / EN ISO 13485:2016
ISO 9001:2015
21 CFR PART 820