Kris Kelly


From his LinkedIn profile:

We provide Quality Assurance Support, Software Quality Assurance & Testing, Performance Tuning and QMS/SDLC Process Improvement expertise with 30+ years experience. Located in San Diego since 2000. We help companies shrink their time-to-market and improve customer satisfaction with their Medical Device, Biotech and Pharmaceutical Products.

We have proven success: Optimized client SDLC process to improve product quality, Re-engineered client SOP’s & crafted reports to pass FDA audit (submittal with intended use validation), Planned & executed software testing for successful new medical device release, Audited software documents to enhance startup product development, Performed QMS gap analysis & remediation to successfully add DNA Instrument to client’s GMP workflow. Conducted integration testing on telehealth system for successful release.

• Software quality engineering/test support for medical devices and hospital systems
• System performance measurement & scaling
• FDA audit preparation
– Premarket notification
– Premarket approval
– Quality management system support
– Good manufacturing practices analysis

• Process improvement
– Analyze and review existing system challenges
– Coordinate team decision for SDLC / QMS process goals
– Collaborate with client team on the remediation plan and execution
– Execute remediation activities with entire client team for maximum desired effect
– Review progress at each milestone in order to ensure expected improvements are tracked
– Implement ongoing process improvement program to ensure continued progress