Medical device manufacturers exporting abroad must comply with the respective country-specific regulations when manufacturing and distributing their products and obtain certification from the individual authorities. This is an enormous effort, both in the alignment and maintenance of the quality management system and in the audits that have to be completed on a regular basis.
To address this situation, the authorities in Australia, Brazil, Japan, Canada and the USA have created a uniform harmonized audit approach in the form of the MDSAP Medical Device Single Audit Program. Once completed, this is recognized by all partner countries. For medical device companies operating internationally, this means a drastic reduction in effort, time and costs. The advantages already come into play when supplying two of the countries mentioned.
The gempex Medical Devices Team supports customers throughout the entire lifecycle of the medical device as an expert in the implementation of QMS requirements and in audit preparation and follow-up.
In the subject area of MDSAP, the experts provide advice with a view to efficiency and a targeted approach. Is participation in the MDSAP program worthwhile for the company in question? How high are the savings? What is the best course of action?
Based on reliable expertise, the customer's situation is examined and a reliable recommendation is made. If desired, the further procedure and the implementation of the required measures can also be accompanied, modularly aligned to the individually requested support. Thus gempex offers versed support on the way to MDSAP certification. Modular selectable service from the initial analysis up to the completed MDSAP audit.
If you have any questions on this topic, please contact Frank Studt, Managing Director at gempex, via contact@gempex.com.