Software development is agile, fast and innovative, while medical device development is often
slow, reactive and change adverse.
SoftComply has developed a set of tools which will help your company comply with the
regulatory requirements with the minimum effort and get your innovative medical devices to
Numerous software companies struggle to enter medical device domain due to strict
regulatory requirements for medical device software products. Similarly, large medical device
manufacturers have a difficult time finding software suppliers that are not only innovative but
also compliant with the regulatory requirements of medical device domain at the same time.
Most medical device manufacturers have been using bulky and rigid development platforms
(ALMs) that support the compliance to various regulatory requirements. These systems are
often too costly for medium and small-sized software development companies.
In order to help developers who use open platforms and tools like JIRA and Confluence in their medical device development, we offer automated support for compliance, particularly in the
time-consuming regulatory requirement aspects of risk management (ISO 14971 & IEC 62304) and quality management (based on FDA 21 CFR 820 and ISO 13485) which save precious developers’ effort to get the products to market.
Did you know that about 25-30% of a developer’s time is devoted to generating the documents for regulatory audits in each medical device software project alone? We help medical device software companies fast-track the development of their Quality Management System with the help of our Atlassian add-on for Confluence, called SoftComply eQMS.
One of the major challenges in developing software for regulated environments is ensuring the safety of the final product. With our JIRA add-on, SoftComply Risk Manager, medical device developers will be able to link risk management activities to their software development
lifecycle and requirements, automate reporting and traceability.
Read more about SoftComply Risk Manager
Read more about SoftComply eQMS