Recognising having a problem is one of the most frequently overlooked problems. Particularly in project management are all the diverse tasks difficult to navigate. External help can be useful - especially for these specific challenges in regulatory affairs surrounding medical devices and in-vitro diagnostics.
Particularly the regulations for medical technology, the therefore requirements for tailor-made CAPA measures and the post-market surveillance activities are of greater importance here as in other areas. Entrepreneurial activity in the medical technology sector is characterised by a multitude of normative and regulatory requirements adding to the usual challenges of running a successful business. If one requirement triggers another and it becomes unclear whether the process is still running efficiently, many teams run into difficulties. In such cases you need more than just a cool head. Then more than ever expert input is greatly important - be it in the implementation or improving the QMS or the preparation of your technical documentation. This is our expertise!
