NAMSA offers clients clinical advisory and validation services in tandem, supported by our fully equipped R&D laboratories. This allows us to deliver Sponsors in-depth insight into testing issues and potential solutions. Areas in which our technical experts typically provide extensive assistance are within the phases of research development, validation of analytical methods and the development and characterization of new sterilization processes.
Test Method Validation for Medical Devices
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Our R&D Teams have a proven track record with the development of successful clinical research methods and validation services utilizing the following techniques:
- Gas Chromatography (GC)
- Gas Chromatography/Mass Spectroscopy (GC/MS)
- High-Performance Liquid Chromatography (HPLC)
- High-Performance Liquid Chromatography/Mass Spectroscopy (HPLC/MS)
- Inductively Coupled Plasma (ICP) Spectroscopy
- Ultraviolet/Visible (UV/VIS) Spectroscopy
NAMSA’s global consultants and senior scientists partner with clients to determine the appropriate analytes of interest for testing. Drawing from resources available in literature, or performing extractables profiles in our chemistry laboratory, our scientists assist clients in the determination of specific analytes of interest for your product. Methods for these analytes are then developed in the presence of your product, ensuring sample preparation procedures are incorporated into these methods. Following the identified method is then validated per ICH guidelines.
The studies involved in NAMSA’s test method validation for medical devices include:
- Linearity testing
- Precision (repeatability and intermediate precision testing)
- Accuracy testing
- Specificity testing
- Limit of detection testing
- Limit of quantification testing
- Range testing
- Robustness and stability of test solutions.
NAMSA’s team of experts can also assist with the development and characterization of new sterilization processes. We offer consulting services on FDA requirements for the testing required for 510(k) submissions for any new sterilization process. With the resources in our other internal disciplines at NAMSA, we can also assist in developing biological and chemical indicators, perform testing to demonstrate that the sterilizer and sterilized materials are safe, and investigate the toxicity of any residuals. In addition, we can provide regulatory guidance on the 510(k) application, up to and including drafting the 510(k).