The Clever Compliance Blog
Our Latest Posts
A blog about product compliance, certification, and product markings.
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.
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.
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?”.
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.
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.
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.
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.
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.
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.
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.