Analysis and guidance documents

All included in GOLD membership.

MDR Distributor/Importer/Manufacturer Quality Agreement

725€ in our store. Free for you.

IVDR Distributor/Importer/Manufacturer Quality Agreement

725€ in our store. Free for you.

MDR Checklist: General Safety and Performance Requirements (Annex I)

725€ in our store. Free for you.

IVDR General Safety and Performance Requirements Checklist

725€ in our store. Free for you.

MDR Clinical Evaluation Plan

725€ in our store. Free for you.

Medical Device Regulation 2017/745 Clinical Evaluation Report: Generalities

725€ in our store. Free for you.

MDR Checklist Labelling & IFU Requirements

725€ in our store. Free for you.

IVDR Checklist Labellling & IFU Requirements

725€ in our store. Free for you.

MDR Comparison ER MDR and 93/42/EC

275€ in our store. Free for you.

IVDR Comparison ER IVDR and Guidance to compliance with the IVDR 2017/746 (29 steps)

115€ in our store. Free for you.

IVDR 2017/746: Strategic Recommendations for Manufacturers

115€ in our store. Free for you.

IVDR E-Book

330€ in our store. Free for you.

MDR Technical File Guidance

330€ in our store. Free for you.

Comparison ER IVDR and 98/79/EC

275€ in our store. Free for you.

Risk Management Template and Guidance

465€ in our store. Free for you.

Post-market surveillance requirements under MDR/IVDR: Guide to manufacturers

330€ in our store. Free for you.

Guidance to compliance with MDR 2017/745

115€ in our store. Free for you.

Understanding the transitional period in MDR

115€ in our store. Free for you.

The Medical Device Regulation 2017/745: Deadlines

65€ in our store. Free for you.

TMT - Transition Management Tool

65€ in our store. Free for you.

MDR E-Book

330€ in our store. Free for you.