Since 1996, the requirements for the development, manufacture and distribution of medical devices in the USA have been laid down in the revised cGMP regulations for medical devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Inspections are primarily performed by the FDA.
Join us at this event, which has been especially designed for manufacturers who are subject to medical device legislation and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.
The seminar will focus on:
- Classification rules and submission in the USA
- Certification procedure
- Technical documentation vs device history file and device master record
- Combination products
- Design controls
- Regulatory audits
- CAPA and complaint handling
We look forward to seeing you there.
For more information, please contact: