Manager Regulatory Affairs International - TÜV, intensive seminar (Module 2)
Produktnummer 08-016-23-EN
- Training Präsenz / Virtuell
- 5 Tage
- Virtuelles Klassenzimmer
- Beginner
- EN
Details
Registration of medical devices on international markets
The English-speaking intensive 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.
Vorteile | Advantages
- 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.
- Familiarize yourself with worldwide registration requirements for medical devices.
Inhalte | Content
- 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, Taiwan, South Korea, 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
- 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
Zielgruppe | Target group
- 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
Hinweis | Note
- An examination is required as part of the seminar. A separate certificate will be issued upon successful completion.
- This seminar deals with internationally valid standards and is also suitable for being held abroad.
- The contents of the seminar correspond to the current state of revision/harmonization.
Duchführende Akademie | Executing Academy
Alle Online Termine dieser Veranstaltung werden von der TÜV SÜD Akademie GmbH in Deutschland durchgeführt. Bei Onlinetrainings gelten daher zusätzlich die Allgemeinen Geschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehen wir Ihnen gerne unter [email protected] zur Verfügung.
