Meeting new standards for Medical Electrical Equipment: IEC 60601-1-2:2014+A1:2020 (EN 60601-1-2:2015+A1:2021)
Services
Extractables & Leachables Regulatory Guidance Services
ÌìÃÀ´«Ã½ provides regulatory guidance services for extractables and leachables to ensure that medicines are of the required quality, safety, and efficacy.
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…
ÌìÃÀ´«Ã½ overview by industry
Happy Holidays from ÌìÃÀ´«Ã½
Resources
Re-Examining the Role of Sulfur and Manganese Properties in Cast Iron
Through the work of literature review and experimental research, ÌìÃÀ´«Ã½â€™s Engaged Expert Richard Gundlach re-examined the roles of Manganese (Mn) and Sulfur (S) on the strength of gray iron.
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…
Services
Microbiological Development and Quality Control Testing
Our microbiology lab provides microbiology testing services and quality control for a variety of drug products, ensuring they are safe, quality, and compliant with relevant regulatory standards.
What are Advisory Services?
Advisory services support manufacturers through the complex nature of qualification testing by engaging clients early on in a project and providing strategic guidance from the outset. From initial concept and then throughout the whole development…
Events
Aerospace and Defence Seminar: Advancing Testing and Certification
Join us on December 6, 2023, at ÌìÃÀ´«Ã½ Wimborne for an Aerospace and Defense Seminar focused on Advancing Testing and Certification. Explore the latest innovations and industry insights to stay at the forefront of aerospace and defense technology.…
Services
California Proposition 65 Compliance for Manufacturers and Distributors
Resources