Building regulatory compliance into the software development life cycle

Safety is the central concern for medical device software development and the development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance.

In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these devices. Due to the increased complexity of software in the devices requiring regulatory review, the time to pre-market approval has increased tremendously. This results in the impediment of innovations in the field as the success of innovations is often dependent on the speed of time-to-market.

Furthermore, the high percentage of medical device recalls due to software failures indicates that despite the regulatory efforts to oversee the safety and quality of new devices, many faulty software systems are still being passed through the compliance audits.

We believe that many aspects of regulatory compliance together with the required documentation can and should be produced as a natural part of the software development life cycle. We want to help companies move away from manual documentation for regulatory compliance that is both time-consuming and error-prone. The best way to do this is through add-ons to software development tools already used by the developers. This is why we have developed regulatory compliance add-ons for JIRA and for Confluence.

Our add-on for JIRA, SoftComply Risk Manager, automates the management of medical device software risks.

Our add-on for Confluence, SoftComply eQMS, fast-tracks the development and management of compliant Quality Management System in your medical device company.

 

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