MedicalMountains GmbH Regulatory Affairs Manager

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 1 deals with aspects of technical documentation, risk management and clinical evaluation, among other things. 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 & dates

module 1
05/25/202 3 Technical documentation according to EU-MDR - structure and content
06/27/202 3 Risk management - Contents and requirements of ISO 14971
07/04/202 3 Biocompatibility and biological safety of medical devices
07/18/202 3 Clinical evaluation and clinical testing of medical devices
25.07.202 3 The usability process for medical device manufacturers - methods and documentation

Test.

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
11/21/2023

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