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Regulatory Submissions:

• FDA – IDE, HDE, HUD, NDA, 510(k), PMA & Combination products
• EU – CE, IVDD, Design Dossier, MDD
• Canadian Health Class I-IV, CMDR
• Japanese Ministry of Health (MHLW)

Computer System Validation for Equipment, Processes and Products:

• IEEE, ISO/IEC, ISPE (GAMP4), SEI (Security, Software Development, & Auditing)
• Integration Verification & Validation

Quality System Requirements (QSR), cGxP’s:

• Development, integration and training of clients staff with Quality System Requirements
• Audits (first and second party) internal, external, pre-FDA inspections, ISO 9001:2000
• Medical Device (21 CFR 820), ISO 13485
• Finished Pharmaceuticals (21CFR 210, 211)
• Biologics (21 CFR 600)
• Human Cell & Tissue (21CFR 1271) 

• Unit, Integration, and System Acceptance Testing
• IOPD/Q’s
• Factory & System Acceptance Testing

• Laboratory Systems (Chemistry, Assays, Automation & Robotics)
• Full Validation cycle (Master Validation Plan) with complete validation documentation

Software Development, Test, Integration and Compliance (V&V) for Class II & III Medical Device

Risk Assessment and Management, Hazard Analysis ISO 14971 &  16085

Human Factor Engineering (AAMI HE48 and FDA)

Corrective and Preventative Action (CAPA)

DFMEA, FMEA, Gage Reliability and Repeatability (G,R&R), SPC & ANOVA

Method Validations for Pharmaceuticals, Medical Devices and Combination Products

IT Network & Infrastructure testing and verification, penetration testing, vulnerability assessments for Internet, Intranet and Extranets

Contract Manufacturing (Proto-types, small production up to 5000 units) in Class 10,000 clean-room

Advanced Medicals Consortium expertise includes: