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 email