QPack for medical device

QPack for medical device

The tough challenge medical device manufacturers are facing includes strict regulations compliancy, especially with the requirements management and on to the validation process. This comes along with the constraints any other development company is facing, such as faster time to market and budget. Medical device manufactures implement QPack Medical Device Lifecycle Management to attack these challenges.
QPack Medical provides a single repository of data management for medical device development, providing tools for all phases such as market requirements, product requirements, risks and hazards and validation. With it's support of content management, change management and compliance with the FDA regulations, it proved s an end-to-end solution for the medical device development process.
QPack medical provides the followings modules:
1. Market requirements
2. Product requirements
3. Electronic records and signatures
4. Document control
5. Change management
6. Audit,
7. Traceability
8. Risks and hazards
9. Validation tools