Comprehensive support to assure safe, effective devices through their lifecycles

• Audits: quality system, ISO 13485, internal, gap, supplier, clinical research study
• ISO 13485-compliant quality management systems: evaluation, development, implementation
  • Gap assessment
  • Evaluation of their current system to define scope, document transfer needs
  • eQMS system recommendations and implementations
  • Transfer of appropriate QMS documentation
  • Recommendations for ongoing activity
• Software security and validation
• Corrective Action/Preventive Action (CAPA)
• Remediation activities (including audit findings, recalls)
• Compliance for start-up companies