Our Services

  • Contract Manufacturing

    - In Certified Class 100,000 cleanrooms 7200 ft2
    - USFDA Registration
    - State of California Medical Device License
    - ISO 13488:2012
    - ISO 9001:2008
    - CE Mark Registration
    - Supplier Audits
    - Compliance with regulations

  • Research, Design & Development

    - Concept Development
    - Prototype Development
    - Pilot Production
    - Clinical Manufacturing
    - Commercial Manufacturing

  • Quality & Regulatory Consulting

    We have established a comprehensive quality management system which will allow the company to meet all of the requirements of the ISO13485:2003, ISO14971:2000(E), ISO9001:2000, USFDA 21CFR and MDD (Medical Devices Directive) 93/42/EEC quality management system standards. Our quality management system concentrates on providing:

    - Defect-free products and services to our customers.
    - Continual improvement to all aspects of our quality management system.
    - The incorporation of technology approaches in our products and services.
    - Competitive pricing for products and services.
    - Products designed to comply with the prevailing regulatory requirements.
    - The incorporation of quality objectives to monitor the quality management.system and provide opportunities for improvement.

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