Simply click the provided links below for detailed information to the listed themes.
Active Implantable Medical Device Directive
AUTHORIZED REPRESENTATIVE
- Authorized Representative – Why & When?
- Product notification requirements?
- Reporting INCIDENTs?
- Product recalls?
- Product removals – Competent Authorities?
- Info exchange – Competent Authorities?
- Clinical Study Notification?
ESSENTIAL REQUIREMENTS
CLINICAL STUDIES
- Regulatory Basics (Annex 7)?
- Study Approval Process?
- Statement of Compliance (Annex 6)?
- Adverse Event reporting?
- Ethics Committee processes?
- GCP Harmonized Standard?
- Clinical Supplies?
CONFORMITY ASSESSMENT
CONFORMITY ASSESSMENT
- Conformity Assessment Options?
- 2. Complete Quality Assurance System?
- 3. EC Type-Examination?
- 4. EC Verification?
- 5. Assurance of Production Quality?