ISO-13485:2003 Quality Systems Consulting and Training

 Services for Bio-Medical and Pharmaceutical Industries

Techlogic, Inc. provides a complete A to Z offering of implementation services for the bio-medical and pharmaceutical industries.   Specific consulting and training services include:

        Baseline assessment (gap analysis)

        Building and facilities audits

        Quality steering team (committee) set-up, implementation, and coordination

        Quality system implementation planning, with detailed timelines

        Registrar selection

        Management and employee quality systems overview training

        Documentation training

        Internal auditor training (quality system, product, process and performance)

        Detailed training for the quality steering team (12 sessions)

        Root cause analysis (RCA) training

        IQ/OQ/PQ and process validation training

        Software validation training

        Management review meeting planning and coordination

        Statistical analysis identification, planning, training, and coordination

        Monitoring and measurement of processes training

        Monitoring and measurement of product training

        Customer satisfaction system definition, implementation, and coordination

        Flowcharting training and consulting (micro and macro) to interconnect processes (organizational and functional levels)

        Product verification and validation training (hardware, software, firmware, and drivers)

        Preventive action definition, implementation, and coordination

        Pre-assessment audit, with full reporting

        On-site assistance during the registration final audit

        Assistance in responding to audit nonconformities and FDA 483s

        Sterilization, bio-burden, and environmental monitoring training and consulting

        Labels and labeling training and consulting

        EU Medical Device Directive (MDD) training and consulting

        Hazard / Risk Analysis, P/DFMEA, and LCA consulting and training

        Essential requirements consulting and training

        Technical file and design dossier consulting and training

        EU Authorized Representative coordination   

        EU Pharmaceutical Directive 65/65/EEU consulting and training

              Clinical and regulatory affairs consulting and training.