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.
Clever Compliance is investing in new digital tools that can help firms easily procure product certification services and streamline their compliance work.
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.
Some often-required types of product certification are CE marking, FDA, FCC and CB Scheme. You can read about each one of these types of product certification here.
Established as a cloud-based CE marking software-as-a-service business, CE Check transforms itself into a global product compliance hub and rebrands as “Clever Compliance”.