Biopass Medical Systems
Medical Device Design and Manufacturing

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Our Software design and development capabilities include:

bullet16.gif (994 bytes) Software development to EN 60601-1-4 and ISO/IEC 12207
bullet16.gif (994 bytes) 21CFR 820.30 design controls
bullet16.gif (994 bytes) Embedded designs
bullet16.gif (994 bytes) Windows™ 95, 98 and NT application development
bullet16.gif (994 bytes) Custom Real Time Operating System (RTOS) development
bullet16.gif (994 bytes) Human factors evaluation
bullet16.gif (994 bytes) Control algorithm development
bullet16.gif (994 bytes) Software configuration management
bullet16.gif (994 bytes) Risk management
bullet16.gif (994 bytes) Software and system integration testing
bullet16.gif (994 bytes) Software verification and validation
bullet16.gif (994 bytes) Software traceability matrixes
bullet16.gif (994 bytes) Completeness and accuracy auditing
bullet16.gif (994 bytes) Anomaly reporting
bullet16.gif (994 bytes) Documentation packages that seamlessly integrate into the DHF.

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