Technical documentation plays a crucial role in demonstrating the safety, performance, and regulatory compliance of medical devices. With the introduction of EUDAMED (European Database on Medical Devices) and GUDID (Global Unique Device Identification Database), comprehensive support for technical documentation is essential.
Key aspects of technical documentation support include:
- EUDAMED Compliance: Ensuring that technical documentation meets EUDAMED requirements for data exchange and transparency.
- GUDID Integration: Integrating with GUDID for unique device identification and data standardization.
- Data Management: Managing and organizing technical documentation in accordance with regulatory standards.
- Version Control: Maintaining accurate version control and documentation updates as required by regulatory changes.
- Effective