Medical Equipment - N/A, N/A, US
Bioscience Pro is a Software Engineering company designed to help Medical Device Manufacturers and startups with their Software Quality Assurance for regulatory compliance and FDA submissions. Bioscience Pro is owned and operated by software engineers with expertise in Medical Device software development, software quality, software V&V, software documentation per ISO 13485, IEC 62304, and IEEE standards. Bioscience Pro provides the following capabilities:- Software Quality Management per IEC 62304. - Software Risk Analysis per ISO 14971.- Software Documentation and Remediation- Software V&V Strategy and Planning- Cybersecurity Concerns, Risk Analysis and Documentation- OTS Validation- Validation of Automated Process Equipment and QS Software
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