医療機器の臨床評価レポートサンプル（無料

ギリッシュ・ヒルパラ レギュラトリー・コンサルタント のKolabtreeでは、MDR準拠のテンプレートとして使用できる医療機器の臨床評価レポートサンプルを提供しています。

The clinical evaluation report (CER) is a mandatory document for medical devices that are to be placed in the EU market. The CER is submitted along with the technical file to meet EU MDR requirements. If compliant, the device is awarded a ‘CE Mark’ which certifies that the device can safely be marketed/sold in the EU.

The clinical evaluation report sample documents the results of the clinical evaluation done for a 医療機器. It includes information on the safety and effectiveness of a device, data from 臨床試験, technical design description, literature searches and more. The CER is specific to one device and has to be continuously updated throughout the life-cycle of the document, and therefore needs constant maintenance.

To help medical device manufacturers understand the overall flow and content of the CER, here’s a FREE sample or CER template that you can download. This document is intended to serve only as reference/guidance for medical device manufacturers.

Girish Hirpara is a メディカルライター with 13 years of clinical research experience. His expertise spans all aspects of 規制遵守 including ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746, ISO- 14155, SOPs, and others. Girishへのプロジェクトのお問い合わせはこちら.

Kolabtree helps you contact freelance CER writers and medical device consultants, on demand. Tap into a global expert network and hire experienced medical device specialists who’ve worked in top companies like Abbott, J&J, Medtronic, Thermo Fisher Scientific, and more. You can also work with researchers who can help you understand with clinical trials, literature search, メディカルライティングなどがあります。
ビュー 臨床評価レポートのフリーランスライター. 今すぐプロジェクトを投稿する