Recent and steep increases in regulatory requirements is reshaping the medical device industry. Compliance has never been so complex or costly. Ensure that you are properly informed and prepared for the new regulations such as the European Medical Device Regulations (MDR) and Medical Device Single Audit Program (MDSAP).
“We had a very successful audit (I’m sure you’ve heard it already). Only one deviation (and one really be sought for). Thank you for handing over such a solid system.”
Quality Manager, medium-sized company
Technology is progressing at an unprecedented rate. Novel and innovative products require a more integrated approach to process development. Secure your compliance and the sustainability of your products and processes.
“We were more than satisfied with how our project goals and your additional services were delivered.”
Supply Chain Engineer, large company
Complex processes within a highly regulated environment make it increasingly difficult to implement improvement or innovation. Reach your project objectives and optimize your Quality Management System.