From the entire pool of test equipment available at our disposal as electronics engineers and technicians, the most useful is undoubtedly the oscilloscope.
How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World
This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.
Time and time again the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is Corrective Action & Preventive Action (CAPA). This article explores those challenges and provides the reader with best practices and ways to improve the CAPA process and approach.
China is the second biggest economy in the world. The strong economic growth of the last decades has lead the country to develop its own quality standardization system. The China Compulsory Certification (CCC) is a system which is comparable, but not identical in terms of standards and requirements to the EU’s CE mark or the FCC’s declaration of conformity in the U.S.
In this month’s EMC Concepts Explained, we explore the conducted immunity test known as a Bulk Current Injection (BCI) test, according to ISO 11452-4 specification . This immunity test is carried out by inducin... Read More...
A VSWR bridge and a magnetic near field probe (NFP) are very valuable tools to find resonances in RF and EMI/EMC applications as tuning, shielding, etc.
Section 7.3 in ANSI/ESD S20.20–2014 includes a requirement for a product qualification plan.
We are pleased to bring you Banana Skins, a new monthly column in In Compliance, and a 20-year tradition that began in the pages of the EMC Journal. We hope you enjoy the column and look forward to continuing the tradition of sharing these valuable stories.