Medical Device Testing
Medical devices must meet stringent safety, quality, and regulatory standards before entering the market. At Keysight Chemtech, we provide comprehensive medical device testing services to help manufacturers ensure that their products are safe, reliable, and compliant with global regulatory requirements.
Our multidisciplinary teams of scientists, toxicologists, and analytical experts conduct detailed evaluation of device materials, components, and packaging systems. Leveraging advanced analytical technologies and internationally recognized testing methodologies, we identify potential risks, assess material compatibility, and generate reliable, submission-ready data to support regulatory approvals.
From early product development through commercialization, our testing services help medical device companies demonstrate product safety, functional performance, and regulatory compliance, enabling faster market entry and reduced development risk.
Our Services
Extractables & Leachables Studies
We conduct detailed E&L studies to identify chemical substances that may migrate from device materials, components, or packaging into the patient environment. These analyses help evaluate potential exposure risks, inform material selection, and ensure compliance with FDA, ISO, and EU MDR standards.
Biocompatibility Testing
Biocompatibility evaluation is essential to confirm that device materials are safe for human contact. Our services include cytotoxicity, sensitization, irritation, and hem compatibility testing, all aligned with ISO 10993 standards, ensuring both patient safety and regulatory compliance.
Toxicological Risk Assessments
Our toxicology experts perform comprehensive risk assessments to evaluate the potential health impacts of chemicals and materials used in medical devices. These assessments help determine safe exposure limits, guide material optimization, and support regulatory approval submissions.
Material Characterization
Our toxicology experts perform comprehensive risk assessments to evaluate the potential health impacts of chemicals and materials used in medical devices. These assessments help determine safe exposure limits, guide material optimization, and support regulatory approval submissions.
Packaging Compatibility Studies
Medical device packaging must protect the product while maintaining sterility, stability, and integrity. Our packaging studies evaluate material interactions, barrier performance, and storage effects, ensuring that devices remain safe and functional throughout their lifecycle.
Regulatory Support Documentation
Keysight Chemtech provides detailed, audit-ready documentation required for regulatory submissions. Our scientific teams prepare data packages, analytical summaries, and validation reports aligned with global regulatory standards, helping clients streamline approval processes and accelerate market entry.
Supporting Safe and Compliant Medical Devices
At Keysight Chemtech, our goal is to help medical device manufacturers navigate complex regulatory landscapes while ensuring product safety and functional performance. By combining scientific expertise, advanced analytical capabilities, and regulatory knowledge, we provide reliable, end-to-end testing solutions that support successful device development and global regulatory approval.