SAE J1455 Testing Considerations
SAE J1455 is the “go-to” test specification for products associated with the automotive market. It is a good fit for developing a test plan for both on and off road vehicles as well as heavy duty trucks.
Resources
Topical Dermatological Drug Development
An Updated Guide to IEC EN 61000 6 2
Updated in 2016, IEC/EN 61000-6-2 is a widely used standard for EMC immunity testing of heavy industrial equipment - find out if it’s the best choice for your product.
Resources
Prototype Testing: When It Applies and How It Works
An overview of prototype testing: how to decide if your product is suited to prototype testing and how the testing is completed, including instances of redesigns and changes.
Cardiovascular Device Crush Fatigue Testing
USP <761> Qualitative and Quantitative NMR Analysis
Acute Particulate Testing of Bioresorbable Scaffolds
Abdominal Aortic Aneurysm (AAA) Testing
AAA devices are much larger than other intravascular devices in both diameter and length, which presents challenges for testing. Element engineers have learned to adapt our equipment to virtually any test application.
Resources
Medical Equipment and PPE Regulatory Reference Guide
Element has compiled a guide to share the proper protocols for U.S. regulatory submission for medical equipment and PPE, as provided by the FDA, CDC and ASTM, to help ensure your products get to market as quickly as possible and into the hands of our…
A Guide to the EN ISO 80079 Standard Series
Read our experts’ guide to EN ISO 80079, the standard series that provides a global set of requirements for mechanical explosion protected equipment, applicable to the ATEX Directive and IECEx scheme.
On-demand webinar: Understanding Radio Approvals and Avoiding Common Pitfalls
Watch our on-demand video where Michael Derby, Technical Director of Regulatory Approvals at Element, provides a look into the basics of radio approvals and requirements.