The Clever Compliance Blog

Our Latest Posts

A blog about product compliance, certification, and product markings.

CE marking

2020-06-25

5 Useful Tools for CE Marking of Products

These tools are particularly suitable for small and medium-sized enterprises (SMEs) and large market players with compliance departments.

CE marking

2020-06-16

The CE Marking Process Explained in 7 Steps

To help out, here is presented a detailed description of all the steps that the CE marking process can include.

CE marking

2020-06-15

5 Questions Often Asked During a CE-Marking Consultation Meeting

Here, you can find answers to 5 questions often asked during a CE-marking consultation and request the help of professionals.

CE marking

2020-05-27

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.

CE marking

2020-03-18

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

2020-03-17

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.

CE marking

2020-03-12

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.

CE marking

2020-03-08

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.

Company news

2020-02-21

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.

FCC

2020-02-04

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.