2021-04-13
Learn what a medical device risk management plan is and how to create one.
2021-04-12
This blog post presents the most common electromagnetic compatibility issues found in electrical equipment.
2021-04-09
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
This article provides information on the new EU Market Surveillance Regulation 2019/1020, coming into force on July 16th, 2021.
2021-03-02
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
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.