What is an EMC Risk Assessment?
The European EMC Directive (2014/30/EU) was updated in 2014, replacing the old directive (2008/108/EC) becoming mandatory from April 2016 for new products entering the EU.
Resources
Q&A on the FDA’s Veterinary Feed Directive Regulation
SAFE
The SAFE program is at the forefront of developing advanced certification systems development over fuselage panels.
How to understand if your material is suitable for its intended purpose
R-Value Testing: is your material effective as a thermal insulator?
What is Digital Image Correlation?
A powerful tool for measuring material properties and strain characteristics, digital image correlation can provide simulated data for large and irregular samples, and for materials that can't be tested using traditional methods.
Meeting new standards for Medical Electrical Equipment: IEC 60601-1-2:2014+A1:2020 (EN 60601-1-2:2015+A1:2021)
Resources
Volatile organic compounds in air by thermal desorption
Our environmental laboratory provides Volatile Organic Compound (VOC) testing by thermal desorption to help you characterize air or soil vapor on your property.
Experts
Medical device manufacturer responsibilities under IEC 60601-1-2 for ongoing EMC compliance
This paper by Steve Hayes discusses manufacturer responsibilities under IEC 60601-1-2 for ongoing EMC compliance in the medical device industry. It emphasizes the need for continual updates to risk management files to address evolving electromagnetic…
ISO 10993-18: An Introduction to Chemical Characterization of Medical Devices
Exploring Extractables & Leachables studies for Orally Inhaled and Nasal Drug Products (OINDP) to ensure delivery system compliance
In this webinar, we'll delve into the materials compliance challenges surrounding inhaler materials, shedding light on the critical aspects that affect patient safety, and presenting you with the information required to safeguard patient health and…