Check out all our MDR templates here – they includes templates for the ISO 13485, IEC 62304, ISO 14971 and IEC 62366. Additionally, we’ve also got templates for the MDR Clinical …

2024年4月13日 · Unsure how to get started and how to get your EU MDR medical device certified? We’ve already helped 100+ companies with their MDR compliance. Take a look at …

2022年3月11日 · Download an MDR 2017/745 Technical File template for free!. This document is a identical copy of the Technical File templates provided by BSI. Using this you will be in full …

2024年4月19日 · You can find the classification rule applicable to your medical device set out in Annexes VIII of the MDR. For example: software intended to provide information used to take …

2023年10月25日 · Save time and effort with our selection of free EU MDR templates. Download them here and ensure compliance with ease. Before you begin (or continue your EU MDR …

A Declaration of Conformity (DoC) is a legally binding document, in which the manufacturer asserts they have met the minimum requirements of the applicable legislation. For example, …

2021年9月24日 · In this article, you will find a quality manual template conforming to the requirements of Regulation 2017/745 and EN ISO 13485:2016 + A11:2021. 👉 This quality …

2020年5月14日 · An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. Use this referenence template for free.

MedQdoc provides 28 templates to support you in compiling the correct technical documentation for your medical device, to meet regulatory requirements. The MedQdoc configuration is built …

The templates were developed by our technical experts and are purely based on MDR requirements, but the interpretation of guidelines and structure is framed based on our …