Templates

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IVDR Addendum to QAgreement distributors

IVDR Addendum to QAgreement importers

IVDR Annual internal audits plan

IVDR Classification template (device only)

IVDR GSPR Checklist

MDR Addendum to QAgreement distributors

MDR Addendum to QAgreement importers

MDR Annual internal audits plan

MDR Classification template (device + accessory)

MDR Classification template (device only)

MDR GSPR Checklist

Traceability matrix

Usability plan

VV Master Plan

List of Applicable Standards

Standards Review Plan

Gap Analysis ISO 14971:2019 to /A11:2021

Declaration of Conformity

Reach Statement

RoHS Declaration

Compliance with eIFU Regulation 2021/2226

Clinical Development Plan

Compliance of the Investigator Brochure with ISO 14155

Compliance of the Clinical Investigation Plan with ISO 14155