content
On the one hand, regulatory affairs managers have the task of working closely with authorities and inspection bodies with regard to national and international specifications and regulations, and of creating and applying the relevant documents. On the other hand, they provide intensive support for risk and quality management. The certificate course enables graduates to move confidently in these demanding and multifaceted subject areas and to initiate and accompany the necessary steps in the company. Module 2 focuses on international approval procedures. The content follows a strict practical orientation.
target group
Employees from the areas of regulatory affairs and quality management, those responsible for the first placing on the market, heads of development, employees who are responsible for compliance with national and international legal regulations, and managing directors.
topic overview
module 2
September 19th + 20th, 2023 Approval procedure for medical devices in the USA (2 days)
10/04/202 3 approval procedures for medical devices in China and Japan & Taiwan
10/18/202 3 approval procedures for medical devices in Brazil, Mexico and Canada
11/09/202 3 approval procedures for medical devices in Singapore (ASEAN), Australia, South Korea and Malaysia
November 21, 2023 Approval procedures for medical devices in Great Britain and Switzerland
Test.
exam and graduation
After each module, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After successfully completing both modules, the participant receives a certificate issued by MedicalMountains GmbH.
a notice
The modules can be booked individually. If these are attended within 2 years, you will receive a certificate. If you book both modules at once, you will receive a special price of EUR 5,490.00.
You can use the links below to find more Modu
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
