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CE-marking support
Clinical evaluations
FDA submissions and inspections
Inspection from regulatory bodies
Quality Management Systems
Risk Management
Software Quality Assurance
Small Business Solutions
Digital Signatures
QMS-in-the-cloud
Audits
Process Validation
Validation strategy
Software validation and Risk Management
Validation of Legacy software
Validation of regulated software
Courses and training sessions
UDI-Coach for management
UDI readiness – Gap analysis
Hands-on guidance on worldwide UDI requirements
Setup of local UDI database
Validation of local UDI database
Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an e-mail
Contact me for further information
Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail
