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SoftQuest Services
SoftQuest Systems offers many services that can support your projects.
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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