MedicalMountains GmbH Double information package for international approvals

Tuttlingen – The regulatory world is also becoming increasingly complex outside of the EU. It is all the more important to stay up to date and to develop pragmatic approaches. This spring, this will happen twice over: with the “International Approval Manager” certificate course, which begins on March 14th, and at the “International Approval of Medical Devices” symposium on March 23rd and 24th.

With an export rate of more than two thirds, foreign business is extremely important for local medical device manufacturers. However, access to markets outside the EU has not become any easier. On the contrary, several countries are upgrading the regulations. So what needs to be considered in practice at the moment - and what chances are there of agreeing on a globally simplified procedure? Both aspects will be included in the symposium “International Approval of Medical Devices” on March 23rd and 24th. The panel is top-class. Among others, Dr. Rainer Edelhäuser, Director of the Central Office of the Federal States for Health Protection for Drugs and Medical Devices (ZLG). Patrick Axtell (FDA) is traveling specially from the USA. He dedicates his lecture to the question "The FDA's eStar process - a model for Europe?" Day 2 focuses on workshops. Together it is about "Best Practices - new approaches", for example about building up global technical documentation and thus being able to create local submissions efficiently.

More information about the symposium “International Approval of Medical Devices” at this link .

With the opening lecture “Approval of medical devices in selected target markets: Where are the changes?” Thorsten Stumpf (Metecon GmbH) laid the basis for the symposium. He also contributes his expertise to a new certificate course: the "International Approval Manager". This offer helps to internalize basic concepts and working methods in regulation and to deepen them further with the help of selected countries. In addition to the USA and China, these countries include Mexico, Canada, Australia, Brazil and Japan, but also Great Britain and Switzerland. Anyone familiar with the further training program at MedicalMountains GmbH will notice that some of the countries are also dealt with by the "Regulatory Affairs Manager". The "International Approval Manager" supplements and deepens this know-how - although it is not a basic requirement. Even participants who start directly in the new course will be able to follow the content well and benefit from it.

Further information on the certificate course "International Approval Manager" under this link.

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