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
Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider
Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider
Integrating the well-respected and trusted Agilis brand and team extends Kymanox’s capabilities in human factors (HF) by adding incredible talent, the ability to conduct HF stu...
Investment Reports Interview with Stephen M. Perry, CEO and Founder of Kymanox
Kymanox CEO and Founder, Stephen M. Perry was interviewed as part of the Investment Reports article, The New Era of Life Sciences 2023, published on 17MAR23,
What were the circumstances that brought Kymanox to life and what does your present foo...
Kymanox Acquires EU Based Anteris Medical and Anteris Helvetia
Leveraging the well-respected anteris brand and team, this acquisition extends Kymanox’s capabilities and geographic reach with a strong European presence
Friday, 03 February 2023
Morrisville, North Carolina, USA and Holzkirchen, Germany an...