Overview about similarities/differences between Medicinal Products and Medical Devices
- Regulatory Submission
- Guidelines
- Supervision
Certification Procedure under the European MDR
- Economic Operators
- Classification of medical devices
- Selection of certification procedure
- Certification by Notified Bodies
Differences between EU and FDA Requirements
- European Requirements
- FDA Requirements
- Differences and common interests
Classification and Premarket Submission of Medical Devices in the USA
- Classification rules in the USA
- IDE
- 510k, PMA
- De novo, HDE
GMP-Related Requirments of EN ISO 13485:2016
- Role of ISO 13485:2016
- Documented procedure
- Key requirements
Technical Documentation vs. DHF/DMR
- Content of Technical Documentation
- Technical Documentation as a linking document between production and quality control
- Change Management – Retests
- Content of the DHF
- Relation to the DMR
- Link to Technical Documentation
- Audit and inspection findings
Combination Products
- The Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products – an overview
- Combination products in the EU – Guidelines and Definitions
- How to classify the combination product
- Conformity assessment
- The consultation procedure
Design Controls
- Introduction of regulatory requirements
- Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
- How to implement Design Controls in the whole life cycle process
- Modern concepts of development of products
- Audit and inspection findings
Qualification and Validation
- Regulatory requirements (FDA, Standards, GHTF)
- Risk assessments
- Qualification
- Validation
- Audit and inspection findings
Regulatory Audits under MDR and MDSAP
- Purpose of the MDSAP
- DSAP Audtiting Organizatons
- Focus point on regulatory audits
- Unannounced audits by Notified Bodies
CAPA/Complaint Handling
- Regulatory requirements (EU, FDA, Standards, GHTF)
- Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
- New ISO 13485:2016 requirements
- CAPA – the motor for continuous improvement
- Monitoring as a subsystem
- Interface complaint handling /CAPA System
- Audit and inspection findings
3 Parallel Workshops concentrating on technical documentation, classification and submission and audit findings, will provide practical orientation:
- Documentation: How to structure a technical documentation
- Classification and Submission of Medical Devices in the USA: How to classify and submit Medical Devices in the USA?
- Preparing for an Audit according to the New European MDR: For two examples of medical devices relevant sections of the new European MDR will be analysed in order to identify the main audit items, which contain new or enhanced requirements.