Small Business Solution

For small and medium size companies we offer services adapted to suit your needs. Ask for our “Small Business Solution” services. These range from short evaluations to comprehensive projects. We are aware that your limited resources and time available. Our solutions are cost-effective.

• Development of a Quality Management System
    o ISO 13485
    o Quality System Regulation
    o 21 CFR 11
    o Design Control
    o Product Software Validation
• Deployment of a Quality Management System
    o SharePoint
    o Digital Signatures with PKI
• Process and Software Validation
    o AAMI TIR 36
    o GAMP  V
• Auditing
    o ISO 19011
    o Certified Lead Auditors
• CE-marking projects
    o Compilation and review of CE marking documentation
    o Technical File, STED
    o Risk Management File
• Part-time Quality Manager
• Regulatory support
    o Worldwide