Medical Device companies designing, manufacturing and marketing their products in the global market must adhere to very strict regulatory, quality and process controls, and must have systems and controls in place to satisfy global regulatory requirements, standards and directives, including those of the US FDA (including 21 CFR part 11 and 21 CFR part 820), European and Asian agencies, as well as ISO standards (including ISO 13485). These systems must comply with and stay current with the continuously evolving and increasingly stringent requirements established by these governing bodies, and also provide the ability to support detailed audits from these agencies and other business partners.
The QUMAS Compliance Platform delivers
- A closed-loop compliance solution, combining all elements of a comprehensive regulatory compliance program, on one platform
- Delivers full capabilities around document & process management for Medical Device organizations
- Access through a unified compliance user interface
- Provides just-in-time learning management
- Presents consolidated reporting & dashboards
- Integrations with drawing and Bill of Materials applications through the QUMAS SDK