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



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