These tools are particularly suitable for small and medium-sized enterprises (SMEs) and large market players with compliance departments.
To help out, here is presented a detailed description of all the steps that the CE marking process can include.
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.
This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.
The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.
The EU Declaration of Conformity is a legal document, wherein a manufacturer formally declares the compliance of a product with the essential requirements of the relevant directives.
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.
FCC certification is a type of product certification for electronic and electrical goods that are manufactured or sold in the United States. Read here all that you need to know about it.