Compliance

Quality System

Malaspina Labs develops technologies which advance the state of the art in defined industries including medical device and communications device manufacture. These manufacturers have formal quality management systems and regulatory compliance requirements.

To maximize the value of our technologies for our customers, Malaspina has established well defined and documented processes to ensure that our technologies are acceptable for use in ISO 9001 development environments and meet FDA or other applicable requirements for Commercial Off The Shelf (COTS) software use in medical devices.

Formal review of engineering artifacts, release management, automated product build & continuous integration testing, and procedurally generated documentation contribute to a corporate culture of professionalism befitting a supplier to medical and communication device manufacturers.

Automated Documentation Generation

Malaspina employs state of the art methodologies such as automated generation of reference documentation from source code, using Darwin Information Typing Architecture (DITA) to ensure that reference documentation is always in-step with and cross-referenced to source code as delivered to customers. 

XML-based content references which are procedurally extracted from source code and assembled into comprehensive technical reference documentation ensure that discrepancies between source code and documentation are a thing of the past.

Automated Testing & Compliance Verification

Malaspina has established well defined processes for validating software behavior and performance against identified use cases and configurations, and reporting that information to customers in a manner that is acceptable for use in their ISO 9001 development environments and meets regulatory requirements for COTS software use in medical devices.  Malaspina employs both procedural and peer-based methods for: