Technical Documentation for CE marking
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.
GAP Analysis: EU MDR Compliance
This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.
CE Marking Medical Device Standalone Software – MDR & IVDR Guide
The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.
Declaration of Conformity Guidance & Template
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.
Medical Device Classification According to the MDR
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, A Revolution in Product Certification
Clever Compliance is investing in new digital tools that can help firms easily procure product certification services and streamline their compliance work.
Do I Need FCC Certification?
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.
4 Types of Product Certification Often Required and Recognised Worldwide
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.
CE Check: Transforming into Global Product Compliance Hub
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”.