Tag: ce marking

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

2021-03-09

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

2021-03-02

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.

Product certification

2020-01-31

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.