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Resources
Electromagnetic Compatibility and Radio Compliance for Medical Devices
In this webinar, EMC Technical Manager David Schaefer discusses basic electromagnetic compatibility requirements under IEC 60601-1-2, the growing field of radio frequency identification (RFID) immunity, wireless coexistence, and more.
A Guide to the EN 55014-1:2017 +A11:2020 Standard Update
Learn more about the updates to the EN 55014-1:2017 +A11:2020 standard and what they mean for manufacturers.
Residence Time and Temperature CFD Study for Incinerators
Learn how Element Digital Engineering's CFD analysis ensures compliance with IED 2010/75/EU for incinerators by optimizing residence time and temperature.
Resources
How to Ensure Regulatory Compliance for your Electronic and Radio Products
As everything is so clearly defined for regulatory approval, it can appear to the manufacturer that there is very little room for risk. However, there are still choices and decisions to be made and with that comes risk.
What You Need to Know About CCMC
Element supports the entire process for evaluating standard products, helping you establish and maintain a CCMC Evaluation listing. Find out more.
Understanding safety and performance requirements for medical device submissions
Downloadable white paper: Pitfalls and safeguards of robust evidence for safety and performance requirements for medical device submissions, from Element RegNav
ATEX Certification and the ATEX Directive
Element offers ATEX Certification and a breadth of technical expertise as a European Notified Body (NB) for the ATEX Directive 2014/34/EU.
Powering The Future Of Mobility
TCE Ban: What Medical Device Manufacturers Need to Know Now
Time is running out for medical device manufacturers still using trichloroethylene (TCE). With the EPA's final ruling having been issued in December 2024, medical device companies have one year to act and avoid production disruptions and compliance…
Services
Battery Testing for Military Applications
Element tests and certifies batteries for a variety of military and defense applications, where failure is not an option.