Material characterization (E&L) ISO10993-18

Material characterization (E&L) ISO10993-18

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Material characterization (E&L) ISO10993-18
Material characterization (E&L) ISO10993-18

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Our material characterization services ensure deep insight into the chemical and physical properties of medical device components. Utilizing advanced analytical techniques (GC-MS, LC-MS), we identify and quantify extractables and leachables (E&L) as per ISO 10993-18. This precise chemical profiling is foundational for mitigating risks and ensuring material consistency throughout the product lifecycle and manufacturing process.
SIRIM Berhad - Life Science CentreM22SIRIM Life Science Centre is Malaysia’s leading industrial research and technology organization, specializing in medical device regulatory compliance. We provide world-class testing and consultancy services under a GLP-compliant framework. By bridging the gap between innovation and market entry, we empower global manufacturers to validate the safety and efficacy of their healthcare products through rigorous, internationally recognized scientific standards.

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