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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