The Clever Compliance Blog
A blog about product compliance, certification, and product markings.
There are several things you can do to improve product compliance management in the workplace. Here are our best compliance tips.
Here, you can find answers to 5 questions often asked during a CE-marking consultation and request the help of professionals.
This article provides a brief overview of what a technical file is and what it should contain. Special attention will be given to the contents of the technical documentation for respiratory products (e.g. face masks) according to the PPE Regulation 2016/425.
The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.
Manufacturers who want to place their medical devices on the European market must refer to the Medical Device Regulation (MDR) 2017/745 to determine the appropriate risk class of their devices.