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Regulatory Compliance
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Compliance Experience, by Industry
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Our senior staff has 130+ years of experience in standards-compliant product development, including life-support, life-critical, and mission-critical systems and software:
- Biomed: Medical Systems, Software and Devices
- Biotech: Pharma/Biologics Delivery Systems
- Biomed & Biotech: ERP, MRP, MES
- Biomed & Biotech: Other Enterprise Systems
- Defense: Space-Borne, Airborne, Sea-Borne, Subsea and Ground-Based systems and software
- NASA: Space-Borne and Ground-Based Systems
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Compliance Experience, by Standard/Regulation
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Experience encompassing many FDA regulations, ISO standards, DOD/MIL standards, including, but not limited to:
- FDA QSR
- FDA GMP
- FDA GTP
- AAMI SW 68
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- ISO 9001
- ISO 12207
- ISO 14971
- ISO 13485
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- MIL-STD-498
- DOD-STD-2168
- GAMP
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