
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