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Our Services

Comprehensive IVDR Technical Documentation Support

Overview

Technical Documentation

We develop and structure complete technical documentation aligned with IVDR Annex II and III requirements.

Our Approach

Documentation Structuring

  • Define Technical File architecture
  • Align with IVDR requirements
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Data Collection

  • Design, manufacturing, and validation data
  • Existing reports and studies
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GSPR Compliance

  • Preparation of Annex I checklist
  • Standards mapping
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Risk Integration

  • Alignment with ISO 14971
  • Link risks with controls and evidence
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Compilation & Review

  • Complete document assembly
  • Internal quality review
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Deliverables

  • Detailed Gap Assessment Report
  • GSPR checklist
  • Submission-ready dossier
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Outcome

Fully structured, compliant documentation ready for Notified Body review.

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Structured IVDR Advisory. Precision in Every Submission.

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Head Office Address

2002, Eleganzo, GB Road, Thane (W)

Days Open

Monday - Friday 09 AM - 06 PM

Contact

+91 91365 97231

Email

info@vermed.in

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