We can support you with a state-of-the-art quality assurance, which is expected in regulated environments. We have experts that can create strategies and plans, set up tool support needed and do the actual work.
Requirements management and traceability, to architecture, Risk Analyses and verification.
– We setup an IEC62304 compliant requirements database for you in Sharepoint or other suitable tools.
Implementation of low-level testing.
– We can help you setup static analyser tools like Resharper, Findbugs, FxCop, etc, with appropriate coding rules.
We can review your test strategies and can help you achieve compliance with IEC 62304 with a minimal process overhead.
– Customized standard procedures, work instructions and templates
– Requirement based testing
– Exploratory testing
In addition to compliance, you gain quality for your products with minimum extra effort. The authorities world-wide are asking more and more for the records from these activities, and the future standards will be more explicit on the expectations.
Contact me for further information Robert Ginsberg
Office +46 8 621 01 05 or send me an mail