Services

The services we provide are:
• Define software quality policy for EN 62304, including software development life cycle
   procedures, templates and forms
• Software Verification and Validation (V&V) according to FDA/CE requirements
• Software Quality Assurance (SQA) in projects and company-wide
• Risk, safety and hazards management
• Implementation of 21 CFR Part 11 (electronic records, electronic signatures)
• Prepare User Manuals
• Training
• Cybersecurity and HIPAA compliance
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