The Clever Compliance Blog

Our Latest Posts

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

Product compliance

2021-04-13

What is Risk Management, and How to Create a Risk Management Plan?

Learn what a medical device risk management plan is and how to create one.

Product compliance

2021-04-12

Most Common Electromagnetic Compatibility Issues in Electrical Equipment

This blog post presents the most common electromagnetic compatibility issues found in electrical equipment.

Product compliance

2021-04-09

A Beginner’s Guide to Product Safety Standards

This article answers questions, such as “What is a standard?”, “What are EN, ISO and IEC standards?” and “How to select the correct safety standards?”.

Product compliance

2021-04-01

A Beginner’s Glossary to Compliance

The following glossary contains key compliance terms and definitions that any new compliance professional must know before diving into the complex regulatory framework for the first time.

FDA

2021-03-26

FDA Approval Process for Medical Devices: Step-by-Step Guide

This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.

Product compliance

2021-03-09

Market Surveillance Regulation (EU) 2019/1020: Does It Apply to You?

This article provides information on the new EU Market Surveillance Regulation 2019/1020, coming into force on July 16th, 2021.

CE marking

2021-03-03

Responsibilities and Mandate of an EU Authorised Representative

This article helps you understand what an EU authorised representative is and what their general responsibilities are.

CE marking

2021-03-02

Medical Device Technical File for MDR Compliance

This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.

CE marking

2021-02-16

10 Medical Device Symbols You Must Know About

MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.

CE marking

2021-02-11

EU MDR Labelling Requirements for Medical Devices

This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.