| 08.00 - 08.30 |
Welcome,
Introduction, Presentation of the Speaker |
| 08.30 - 09.30 |
Regulatory
Requirements
- European Directive
- FDA
- Norms
- Notified Body
|
| 09.30 - 10.30 |
Differences between
EC and FDA Requirements
- European Requirements
- FDA Requirments
- Differences and common interests
|
| 10.30 - 10.45 |
Break
|
| 10.45 - 11.45 |
CE-Certification
- Requirements of the EC Directive
- Use of the norms
- Certification Process
|
| 11.45 - 12.45 |
ISO Certification
- Implementing a system
- ISO 9001 as basic norm
- ISO 13485 as a basic norm
- Procedure of certification
|
| 12.45 - 13.45 |
Lunch
|
| 13.45 - 14.45 |
Technical
Documentation
- Content of the TD
- TD as a linking document between
production and quality control
- Change Managemen
|
| 14.45 - 15.00 |
Break
|
| 15.00 - 16.00 |
Device History
File/Device Master Record
|
| 16.00 - 17.00 |
Special Requirements
for Medical Devices
- Risk analyses
- Sterilisation
- Validation of processes
- Supervision of contract
manufacturer
|
| 17.00 - 18.00 |
Performance of Audits
- Preparing for an Audit
- Performance of an Audit
- Nuts and bolts
of an Audit
- The Audit report
|
| 18.00 - 18.30 |
Discussion
|
