Manager Regulatory Affairs International - TÜV, intensive seminar (Module 2) | English
The english speaking intensiv seminar Manager Regulatory Affairs International – TÜV (Module 2) qualifies you to speed up approvals on the key international markets. You know the various framework conditions and approval requirements in the key target markets. Within the scope of regulatory affairs, you can take responsibility for the global registration of your medical devices.
- Approval of medical devices in Asia
- Regulatory framework, procedure for approval in the respective countries and necessary documentation
- Country specifics for the following countries: China, Singapore, Malaysia, Japan
- Approval of medical devices in Canada, Brazil, Mexico, Australia
- Medical device approval procedures in the states: Canada, Brazil, Mexico, Australia
- Procedure for approval in the respective countries and preparation of the necessary documentation
- Medical Device Single Audit Program (MDSAP) - requirements and preparation
- Presentation of the MDSAP audit model
- Changes in current audits
- Approval of medical devices in the U.S. - Basic course
- US market for medical devices
- FDA requirements
- Approval of medical devices in the U.S. - Advanced course 510(k)
- 510(k) premarket notification requirements
- Procedures and decision criteria for changes to an existing medical device
- Obtain high-class training and qualify as Manager Regulatory Affairs International – TÜV in a very short time.
- Gain an overview of all important parameters in the medical device industry.
- Familiarise yourself with worldwide registration requirements for medical devices.
- Newcomers in the medical device industry
- Expert and executive personnel that want to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Engineers in the medical device industry
- Consultants in the medical device industry
Certificate Manager Regulatory Affairs – TÜV (Module 1)
An examination is required as part of the seminar. Upon successful passing, a separate certificate will be issued.
English
Certificate TÜV SÜD Academy
Dieses Onlinetraining wird von der TÜV SÜD Akademie GmbHin Deutschland durchgeführt. Bei diesem Onlinetraining gelten daher die AllgemeinenGeschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehenwir Ihnen gerne zur Verfügung.
This training is being operated by TÜV SÜD Akademie GmbHin Germany. The GeneralTerms and Conditions as well as the PrivacyNotice of TÜV SÜD Akademie GmbH apply. Incase of any questions, do not hesitate to contact us.