Resources

Resources.

Resources, insights and downloads related to medical and regulatory writing for medical devices and IVDs.

Downloads.

Check out our downloads and ready-to-use templates!

MDR-Compliant Literature Review Protocol Template

Literature Review Protocol Template

Get a structured literature review protocol template for medical devices, including all necessary sections for MDR and IVD compliance....
Literature Review Report Template

Literature Review Report Template

Download a structured literature review report template for medical devices. Perfect for systematic reviews under MDR compliance guidelines....

Insights.

Insights on medical and regulatory writing for medical devices and IVDs.

Summary of Safety and Clinical Performance (SSCP) for Medical Devices

The SSCP is a publicly available document summarizing safety and performance data on a medical device. It is intended to...
Clinical evaluations under the MDR

Conducting MDR-compliant Clinical Evaluations for Medical Devices

Clinical evaluation is a systematic process used to appraise and analyze clinical data related to a medical device. It compiles...
Role of Literature Reviews in MDR Compliance for Medical Devices

The central role of literature review for medical devices under the MDR.

Within the medical device industry, the European Medical Device Regulations (MDR) 2017/745 has introduced new challenges, increasing the scrutiny of...