The join offering from Inflectra and Inmarsys Limited will drive forward the efforts to ensure their customers' compliance with the USA's HIPAA, FDA's 21 CFR Part 11, FDA's 510(k)), IEC62304 as well as the UK's BSI among other international standards.
"As Inflectra works to mature our enterprise risk module in the company's flagship portfolio management platform - SpiraPlan, we look forward to integrating Inmarsys's wide-ranging expertise in the medical device manufacturing and healthcare industries to bring a superior solution to the market". said Adam Sandman, the CEO of Inflectra.
About Inmarsys Limited:
Inmarsys Limited has over 20 years in Safety-Critical software development industries such as Medical, Aerospace, and Automotive. Inmarsys Limited helps clients strengthen their Medical device development programs and drive the software in these programs to successful certifications (CE and FDA 510(k)/de Novo).
the company offers a complete IEC62304-compliant SDLC creation, SDLC integration with ISO13485 QMS processes, assistance in ISO14971 Risk Management, product architecture design, and embedded software implementation for Medical devices (MDs) and In-Vitro Diagnostics devices (IVDs).
About Inflectra:
Founded in 2006, Inflectra is a market leader in software test management, test automation, application lifecycle management, and enterprise portfolio management space. The company is headquartered in the USA but has offices in over 10 countries. Known globally for its legendary customer support, Inflectra makes turn-key solutions that address many challenges in software testing and QA, test automation, and product lifecycle management. Its methodology agnostic software tools are used in regulated industries where portfolio management, requirements traceability, release planning, resource management, document workflow, baselining, and enterprise risk analysis are required. The company uses a concurrent pricing model for all its tools with unlimited products, projects, sprints, tests, API calls, included in a single price. All Inflectra products have a 30-day free trial.