Small Business Solutions

For small and medium-sized companies, we offer tailored services —just ask for our ” Small Business Solutions” services. These range from small-scale evaluations to comprehensive projects. We are aware that your resources are limited and that time is scarce. Our solutions are always cost-effective.

  • Quality management system (QMS) development and deployment– ISO 13485
    – Quality System Regulation, 21 C.F.R. 820
    -SharePoint, digital signatures, 21 C.R.F. Part 11
  • Design control
  • Product software validation
  • Process and computer systems validation
    – AAMI TIR 36 and IEC/TR 80002-2
    – GAMP V
  • Auditing
    – ISO 19011
    – Certified Lead Auditors
  • CE marking projects
    – Compilation and review of CE marking documentation
    – Technical File, STED
    – Risk management file
  • Part-time experienced Quality Manager

Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an mail