Medical Device Testing
Comprehensive Chemical Characterization, Analytical Testing And Quality Evaluation Supporting Medical Device Safety And Compliance
OUR PRE CLINICAL SERVICES
Medical Device Testing
Comprehensive medical device testing services covering chemical characterization, extractable and leachable evaluations, cleaning validation, and elemental impurities assessment in accordance with ICH, ISO, and global pharmacopeial guidelines.
Medical Device Testing Services Scope
Chemical Characterization (Extractable & Leachable) With Toxicological Risk Assessment- Analytical Method Development
- Analytical Method Verification/Validation As Per ICH And ISO Guidelines
- Cleaning Validation
- Stability Testing As Per ICH And ISO Guidelines
- Elemental Impurities Analysis As Per ICH
Our Process
Our Approach To Accurate &
Compliant Testing
Build your career in a research environment that values scientific curiosity, quality and teamwork. At Ribosome Research Centre, people
contribute to work that supports the understanding of products and the evidence behind development decisions.
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
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