Chemical Characterization for Medical Devices
ASTM Methods, EO Residue, ECH Residue etc...
The Challenge:
To Understand Chemical Characterization to Ensue a Safe and Compliant Medical Device and In the medical device industry, ensuring safety and compliance with regulatory standards is paramount. Chemical characterization and biocompatibility testing are essential steps in this process, guided by frameworks such as ISO 10993. These evaluations help manufacturers understand the materials in their devices and assess potential health risks to patients.
Our Approach:
Our laboratory conducts rigorous Chemical Characterization for Medical Devices using recognized ASTM and ISO methods. We develop and validate custom extraction and detection methods to identify and quantify any residual chemicals from the manufacturing process.
Our Expertise
We provide comprehensive chemical characterization of medical devices in compliance with relevant ISO guidelines( 10993-12 and 18 ) and standards.
To date, we have successfully executed about 70 + medical device chemical characterization projects, covering diverse materials, components, and product applications. Our expertise enables us to deliver scientifically robust, reliable, and regulatory-compliant analytical solutions to support pharmaceutical and medical device manufacturers throughout product development and regulatory submissions.
Why It Matters
Track Record
Applications
- Orthopedic implants
- Cardiovascular devices
- Reusable surgical instruments
- Polymeric components
Regulatory Standards
Instrumentation
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.