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Medical Device Consulting

"Quality is never an accident; It is always the result of
high intention, sincere effort, intelligent direction and skillful execution; It represents the wise choice of many alternatives"

Our Services

Medical Device Consulting


  • QMS/eQMS Implementation and/or Management

  • Risk Management

  • CAPAs

  • Audit Execution

  • Training


  • Strategies

  • Submissions

  • Remediation

  • Compliance

  • EU MDR and QMSR Transitions

technical services

  • Technical writing

  • Validation, Verification and Qualification Plans

  • Statistical Analyses

  • Test Laboratory Sourcing


  • Site Qualification

  • Site Monitoring

  • Study Audits

  • TMF/eTMF Preparation and Maintenance

project management

  • Project Planning

  • Plan Execution

  • Resource Allocation and Management


  • Internship

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