content
When it comes to the approval of medical devices, one is confronted with an increasingly complex regulatory world. The certificate course should help to internalize basic concepts and working methods in regulation and to deepen them further using selected countries.
target group
Employees from the areas of regulatory affairs and quality management, those responsible for the first placing on the market, employees who are responsible for compliance with national and international legal regulations.
Topic overview & dates
03/14/2023 Basics in Regulatory Affairs International
Regulatory work | Regulatory Writing | General Approval Procedure | Monitoring of regulatory provisions / working with regulatory databases (internal) | Maintaining Country Approvals | Stakeholders in international approval
03/30/2023 Approval process for medical devices in the USA
Regulatory Framework and Opportunities in the US | Creation of country-specific documentation | Working with regulatory databases | Product Registration
04/25/2023 Approval procedure for medical devices in China
Regulatory Framework and Opportunities in China | Dealing with language barriers | Cooperation with local partners
05/09/2023 Approval procedures for medical devices in Mexico, Canada and Australia
Regulatory Frameworks and Opportunities in Mexico, Canada and Australia | Use of existing national approvals | Process models and requirements for state approvals | Change management / maintenance of country approvals
05/24/2023 Approval procedures for medical devices in Brazil and Japan
Regulatory Framework and Opportunities in Brazil and Japan | Variants in the QMS | Benefits of MDSAP | Dealing with license holders on site
06/13/2023 Approval procedure for medical devices in Great Britain and Switzerland
Regulatory Framework and Opportunities in UK and Switzerland | Dealing with changing markets
06/29/2023 Summary and communication
Summary of the country approvals / any open questions from the participants | Communication with regulatory stakeholders | Communication exercises
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.
a notice
Participants who have already completed Module 2 for Regulatory Affairs Managers will receive further content in this course that builds on it.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Online
