Clinical Affairs - Cord Schloetelburg

Clinical Evaluation of Medical Devices

Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).

Usability - Cord Schloetelburg

Usability Engineering for Medical Devices: IEC 62366

In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.

Medical Software - Cord Schloetelburg

Software Life Cycle for Medical Devices: IEC 62304

In this article we give an overview of the software life cycle of medical devices and the corresponding standards.

Risk Management - Cord Schloetelburg

Risk Management for Medical Devices: ISO 14971

The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.

A shild with an eye on it, symbolizing GDPR principles A shild with an eye on it, symbolizing GDPR principles

GDPR Principles and Medical Software: Privacy by Design is King

The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.

Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices

Product Liability and Medical Software: Fortunately You Can Insure Yourself

Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.

EU MDR Factsheet for Manufacturers of Medical Devices

Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.

footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification

Medical Device Certification Based on the New EU MDR: a Step by Step Guide

Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.