This article presents five reasons why risk management is important and information on how to ensure you make risk-free medical devices.
Learn what a medical device risk management plan is and how to create one.
This blog post presents the most common electromagnetic compatibility issues found in electrical equipment.
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?”.
This article provides information on the new EU Market Surveillance Regulation 2019/1020, coming into force on July 16th, 2021.
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.
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.