- Understanding the key changes of the transition from the Directive to the New Regulation
- Communicating the impact of key changes
- Identifying the key steps for your organisation
- Explaining the impacts on QMS
Manufacturers/sub-contractors/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, etc.
– Project managers, engineers
- Introduction and objectives
- Definition and classification of a medical device under the Regulations
- New key requirements: the extra evidence to be provided
- Recast: implementing technical dossier Annex II and III
- Quality Management System: translating requirements into procedures
- PMCF, PMS, PSUR, etc. What oversight should be implemented post market launch?
- Transition schedule: When must one be ready?
- Basic knowledge of medical device regulations
- Knowledge of Directive 93/42/EEC
7-hour classroom attendance