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.
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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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Meet our Test Engineering Experts

Nick Ciccarelli, PE
CHIEF TECHNOLOGY OFFICER

Markets That Benefit from Our Test Engineering Solutions

Combination Products

Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.

Biologics & Cell and Gene Therapy Services

We understand why “the product is the process” and how to implement solutions to your unique challenges.

Pharmaceuticals

Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.

Medical Devices & Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

The Kymanox Test Engineering Difference

Kymanox offers a forward-thinking approach to the product development lifecycle, accessing both industry-leading technologies and disruptive innovations to position products for commercial success.
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Comprehensive Solutions

Our team applies Kymanox’s development toolkit of project management, development, and quality management tools that can be customized to the needs of your company and project to ensure efficient and “fit for purpose” solutions to meet your project objectives.
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Turnkey Support

Our team's broad experience and integrated development approach ensure the Right First Time products for unmet patient needs in accordance with US FDA, EU EMA, and rest-of-world regulatory requirements.
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Unmatched Expertise

We offer unmatched experience and knowledge across pharmaceuticals, biologics, medical devices, combination products, and "in vitro" diagnostics, so we are equipped to tackle any project in these areas. Our Development leads serve as a central hub to leverage subject matter experts from across the organization.
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