Meeting new standards for Medical Electrical Equipment: IEC 60601-1-2:2014+A1:2020 (EN 60601-1-2:2015+A1:2021)
Automotive Trim Testing
Services
Extractables & Leachables Regulatory Guidance Services
Element provides regulatory guidance services for extractables and leachables to ensure that medicines are of the required quality, safety, and efficacy.
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Stress Corrosion Cracking (SCC) Testing
Stress corrosion cracking testing: evaluate the susceptibility of your metals to cracking failure under tensile stress and corrosion.
Integrity Assurance to Determine Additive Manufacturing Safety for Critical Components
Working with UKAEA, inspection bodies, and aerospace companies, we developed a risk-based analysis methodology that assessed the fatigue lives for an otherwise perfect component based on a number of worst-case potential flaws then statistically…
Cleaning Validation & Verification Services
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Orthopedic Device Testing
Element offers a comprehensive suite of testing for orthopedic devices including hip, knee, spinal and dental implants.
Resources
Re-Examining the Role of Sulfur and Manganese Properties in Cast Iron
Through the work of literature review and experimental research, Element’s Engaged Expert Richard Gundlach re-examined the roles of Manganese (Mn) and Sulfur (S) on the strength of gray iron.
Ground Penetrating Radar Testing
Element Materials Technology provides a full spectrum of Non Destructive Evaluation and Non Destructive Testing services for concrete structures and materials.
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…