With vast experience in testing and validating critical software products that are at the core of safety-critical/life-saving systems, OAKSYS focusses on the intent of requirements and their fulfilment in the software product. Medical Devices and Pharmaceutical Applications must be certified by the competent certification authorities before they are used.
OAKSYS understands the concepts and expectations of 21 CFR Part 11, IEC61508, HIPAA and such other models and standards. We can provide Independent Verification and Validation (IV&V) services and Software Testing services meeting the stringent requirements of the certification. The critical requirements are clearly understood under these standards and the software is validated at the appropriate level of criticality. We are an AS9100D and ISO 9001:2015 certified company. We follow software processes that are tailored from CMMi, AS9100 and IEEE standards. We have strong expertise in use of automation tools.
Some of the key programs that we participated are –
- Testing of subsystems of Medical devices – Cardiovascular, Ultrasound, X-Ray devices
- Testing and Test Automation of analytical software products that provide proactive intelligence on care, cost and compliance quality for health care industry
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