FAQ: Wireless Coexistence Testing for Medical Devices

FAQ: Wireless Coexistence Testing for Medical Devices What wireless technology that is used in the medical device can E&E test?  Eurofins E &E developed a methodology to evaluate medical devices, depending on their wireless functions (Wi-Fi, Bluetooth, ZigBee), operating up to 7.2GHz ISM bands for the following wireless technology systems: IEEE 802.11a/b/g/n/j/p Long-Term Evolution (LTE,... Read More

Eurofins E&E Is Now An FDA ASCA-Accredited Laboratory For Medical Device Testing

On April 12th, 2021, Eurofins E&E North America, an accredited ISO/IEC 17025 test laboratory, achieved ASCA recognition by the U.S. Food and Drug Administration (FDA), for Premarket Testing of Medical Devices. Launched on September 25th, 2020, the voluntary  Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program was devised to enhance consistency and predictability in the... Read More

Eurofins’ Finland’s Notified Body Achieves Designation Under the New Medical Devices Regulation (EU) 2017/745

On April 7th, 2021, Eurofins Expert Services Oy (No. 0537) became a Notified Body designated under the new Medical Devices Regulation (MDR). Eurofins can now offer, to medical device manufacturers worldwide, certification services according to Regulation (EU) 2017/745 for European market access covering an extensive range of medical device technologies1. The new Medical Device Regulation... Read More

FAQ: Risk Management for IEC 60601-1

FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More

IEC 60601-1-2 4th Edition Medical EMC Webinar

In the 60601-1-2 4th Edition webinar, you will learn about changes coming with the 4th edition of the IEC 60601-1-2 standard. Topics include technical requirements, updates coming with the 4th edition of 60601-1-2, steps the manufacturer must perform to fulfill risk management requirements, new methods of risk analysis and immunity requirements to mitigate interference and... Read More

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of... Read More

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

IEC 60601-1 Third Edition Amendment 1 (Ed. 3.1) What you need to know For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding... Read More

IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets

The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world.  IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries.  Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO... Read More