Experts
Alex Brumpton
With over 10 years of experience, Alex supports global medical device manufacturers with navigating the complexities of the international medical regulatory landscape, specializing in compliance, particularly in product safety and IEC 60950-1.
Services
JMI SENTRY Antimicrobial Surveillance Program
Services
Shelf Life Testing
Element’s shelf-life study food services provide the reliable data required to help you ensure your food product’s stability up to the promised best before date.
Services
Electrochemical Migration (ECM) Testing
Protect your printed circuit boards against failure in the field with electrochemical migration (ECM) testing from the experts at Element.
Services
Microbiology Testing of Treated Articles
Element provides expert antimicrobial treated article testing to a variety of microbiology methods, including ASTM E2149 and ASTM E2180, AATCC 100, JIS Z2801/ISO 22196, and more.
Blood Pressure Monitor Clinical Validation Testing
Element provides turnkey solutions for invasive arterial and non-invasive blood pressure testing for focused development tests as well as FDA and other regulatory agency submissions. Our experienced team will take care of protocol design, IRB…
Services
Solid-State Characterization of Active Pharmaceutical Ingredients (APIs) and Excipients
Our chemical analysis laboratories provide polymorph and crystal identification of Active Pharmaceutical Ingredients via XRPD, DSC, FTIR, and SEM to determine the best polymorphic form for your product.
Services
Q1/Q2(Q3) Pharmaceutical Deformulation and Reverse Engineering
Services
Wireless Medical Device
Services
Digital Image Correlation (DIC) Services
Element’s digital image correlation (DIC) services provide the most accurate data possible about a material’s mechanical strength and stress characteristics.
Services
Contaminant Analysis and Complaints Investigations
Our contamination detection and analysis services isolate and identify unknown particulates and contaminants in pharmaceuticals and biologics down to trace levels.