Selected ShoeBar Projects
- Pain-Relief Device Manufacturer: Advised and assisted in developing software quality procedures. Helped host quality audit conducted by partner company (a multinational pharmaceutical firm). Conducted audit of external software developer, for compliance with relevant sections of IEC 62304. Documented and performed validation of defect-tracking tool.
- Major pharmaceutical company, medical device group: conducted and documented internal audit of software development group.
- Medical device startup: developed initial software quality procedures, advised on design documentation, helped develop FMEA for risk analysis, introduced concept of Impact Mapping for high-level product overview, established draft verification & validation plan.
- Infusion system company: reviewed / revised software development documentation, reviewed hazard analysis, advised on software development procedures, advised on regulatory concerns for new-product plans.
- Gastric balloon system company: reviewed / reorganized software requirements / design / hazard analysis / test documentation in preparation for an IND submission.
- IVUS imaging company: conducted and documented validation of multiple tools used for product software development and testing. Modified or created several SOPs related to software tool validation.
- Respiratory-volume device company: evaluated and revised software documentation (requirements, design, testing, risk analysis, off-the-shelf software documentation).