Go to Client Portal
NAMSA
Medical Device Testing

Test Method Validation for Medical Devices

GAIN IN-DEPTH INSIGHT INTO TESTING CHALLENGES AND THEIR SOLUTIONS.

Contact Us

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.

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).

Resources

White Paper
Achieving EU and U.S. Commercialization Success: The Critical Linkage Between Reimbursement and Regulatory Strategies
Learn More
Webinar
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
Learn More
White Paper
Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 & EU MDR Updates
Learn More
Webinar
Software as a Medical Device (SAMD): Qualifications & Regulatory Requirements
Learn More
White Paper
How to Select the Proper EU Notified Body for your Medical Device Organization
Learn More
Webinar
EU MDR Part 1: Current Opportunities & Challenges with Clinical Data-A NAMSA Panel Discussion
Learn More
Webinar
EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management & Biostatistics
Learn More