CONSULTING

Consulting

NOT SURE HOW TO FIND YOUR WAY

to ISO 13485 certification, CE marking and market access?

AstraConsulting - answers to your regulatory questions

Understanding and acting efficiently on regulations like MDR and IVDR is often complicated. Like a mountain guide, our experts will guide you to the top of the regulatory mountain, according to your individual needs and skill sets. Particularly, they will answer all your questions in the best possible way and thereby help you find the most relaxing, safest, fastest, shortest or most instructive regulatory route. You can count on our answers to bring you closer to your goal – ISO 13485 certification or CE marking and market approval of your IVD or medical device.

Just choose one of the following options.

The new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have had a huge impact on the MedTech industry with all its economic operators. In order to ease your burden, we offer strategic consulting to tackle important decisions, such as:

  • Which milestones are to be reached?
  • When is the optimal time point to change to the new MDR in case of legacy devices?
  • How to prepare Technical Documentation to comply with the new MDR?
  • How can resources be allocated to fulfill requirements best?
  • Is interim support needed on specific topics?
  • What changes do Private Label Manufacturer have to implement?

Additionally, we assist with the communication with national and international Competent Authorities, Notified Bodies and Expert Panels.