Our Test Engineering Skillsets

Our experienced team has a diverse background in medical device test method development, including areas such as drug delivery systems, combination products, catheters, and orthopedics. The team has expertise in DV testing, data acquisition systems, sterilization studies, testing in support of Human Factor (HF) studies, QA release testing, and more. We are experienced in testing and documentation in a QMS environment (ISO 9001, ISO 13485, 21CFR820) and are proficient in the latest quality standards and regulatory requirements.

Test Engineering

Kymanox® Test Engineering Services offer support at various stages of product development, reducing development time and increasing quality and reliability. Testing and empirical evaluations are critical throughout the product development cycle to, for example, evaluate concept feasibility, understand design margin, or support root cause analysis. A proactive approach can set a design up for success in Design Verification (DV) through early testing and development of the DV framework.

Kymanox offers expertise in:

Test method development (CCI/sterility maintenance, force testing, pressure testing, biocompatibility approach, sterilization approach, and more), test fixture design, test method validation and gauge R&R, training and technical transfer, development of test protocol and test plan, and study design.
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We can also help with:

Design of Experiments (DOE), sample size determination and reduction, data analysis and statistics, accelerated aging and conditioning using our environmental and vacuum chambers, and dose accuracy and delivery profile testing.
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Kymanox engineers offer:

Root Cause Analysis, custom electrical test fixture and method development, Data Acquisition (DAQ), logging, post processing, analysis, and data visualization, circuit performance testing, and testing in support of Human Factors studies.
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