EU-IVDR Technical File Remediation
Introduction
In Vitro Diagnostic Manufacturer
Our client is a leader in high-quality, innovative diagnostic products for the determination of blood groups (anti-Duffy and anti-Kidd). They are located in the US with operations globally.
Standards & Tools
- EU-IVDR 2017-746
- ISO 13485
- ISO 14971
- GDPR
- Word Excel
- Powerpoint
Scope of work
3 Technical Files converted from IVDD to IVDR
PEP and PER authoring
Produce plans for post-market surveillance and post-market performance follow-up
Review and audit of QMS to ISO:13485
Gap Assessment and device diagnostics report
Updated Risk Management Procedure
Internal and external auditing support
Key numbers
Team
2 FTE
Location
Boston, MA
Length
9 months, 2 days per week
Type
CTA
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