MCI includes within its scope of accreditation the Analysis of Ethylene Oxide in medical devices
We are pleased to announce that we have reached a new milestone in our commitment to quality and safety in the medical device sector. Our analysis of ethylene oxide in medical devices and 2-chloroethanol (ECH) has been included within our scope of accreditation under the international standard ISO/IEC 17025:2017 by IAS (International Accreditation Service), thus guaranteeing the reliability and accuracy of our results.
Validated and accredited analysis
Following a rigorous validation process, we have obtained accreditation for the detection and quantification of ethylene oxide residues in medical devices, ensuring compliance with ISO 10993-7. This accreditation reinforces our position as a reference laboratory in the sector, offering reliable results and complying with the highest international standards. See our accreditation on the IAS website.
Cutting-edge technology
At our facilities, we have state-of-the-art equipment that guarantees the accuracy and reproducibility of the results. In addition, our procedures are subject to periodic audits by IAS, ensuring that our operations remain aligned with the most demanding requirements in the industry.
Advantages of our analysis of ethylene in medical devices
Our analysis service is designed to meet the specific needs of the medical device sector, with a focus on:
- Simulated and exhaustive extraction: We apply methods such as immersion and flow in the fluid channel to evaluate the presence of this gas in medical devices.
- Speed and efficiency: strategically located near sterilization companies, we facilitate the logistics for the analysis and delivery of results.
- Reduced costs and turn-around times: By performing the analyses locally, we eliminate the need to send samples abroad, which represents a significant saving in costs and response times.
Logistics and sample shipping
To ensure sample integrity, samples must be shipped on dry ice. We offer the option of direct collection from your sterilization provider, upon prior coordination, ensuring a smooth and efficient process.
With this accreditation, MCI reaffirms its commitment to quality, safety and innovation in the analysis of ethylene oxide in medical devices, contributing to the safety and efficacy of medical devices globally. Please do not hesitate to contact our team of experts to resolve any questions or request a proposal.
