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
Neuma’s 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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NEUMA 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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NEUMA 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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Nick Ciccarelli, PE
EXECUTIVE VICE PRESIDENT, DEVELOPMENT
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.
The NEUMA Test Engineering Difference
NEUMA offers a forward-thinking approach to the product development lifecycle, accessing both industry-leading technologies and disruptive innovations to position products for commercial success.
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.
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.
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.
Read the Latest at Kymanox
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The Factor Podcast: Transforming Nursing Through Innovation and The Evolving Role of Nurses in Advancing Patient-Centered Care
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, we speak with industry leader, Dr. Bonnie Clipper, to discuss innovations in technologies to empower nurses and improve patient care. Dr. Bonnie C...
The Factor Podcast: Exploring EUDAMED Requirements for EU MDR
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this informative episode of The Factor, we sit down with industry experts, Dr. Christiana Hofmann and Richard Houlihan, to discuss EU MDR's implementa...