Analysis and guidance documents

All included in GOLD membership.

MDR - Checklist compliance with information supplied with the medical dev

385€ in our store. Free for you.

IVDR - Checklist compliance with information supplied with the In vitro diagnostic medical device

385€ 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.

MDR Technical File Guidance

330€ in our store. Free for you.

IVDR E-Book

330€ 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.

MDR Technical File Guidance

330€ in our store. Free for you.

MDR E-Book

330€ in our store. Free for you.

Comparison ER IVDR and 98/79/EC

275€ in our store. Free for you.