2021-04-19
Top 5 Reasons Why Risk Management is Important
This article presents five reasons why risk management is important and information on how to ensure you make risk-free medical devices.
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?”.
2021-03-09
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.
2021-03-02
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.
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.