NEUMA, The Design And Testing Arm Of Kymanox, Moves To New Headquarters

Kymanox Corporation (“Kymanox”), a professional services company exclusively serving the life science industry, announced today that NEUMA, an engineering services provider specializing in product development of drug delivery devices and combination products, moved its service headquarters and laboratory to 935 First Avenue in King of Prussia, Pennsylvania USA.

The new NEUMA headquarters provides a significant upgrade in meeting space for customer engagement as well as expanded lab space for prototyping and testing. In particular, this new space enables the Kymanox Lab Services function to offer full-service Design Verification (DV) Testing activities, from early-stage test method development through method validation and DV execution. The lab services are supported with a full-functioning Quality Management System (QMS) in accordance with FDA requirements.

In addition to design and testing services, NEUMA continues to expand its service offerings particularly in the field of sterilization engineering. At the end of 2022, Shaun Devitt, Director at Kymanox and one of the original cofounders of NEUMA, achieved formal certification from the Association for the Advancement of Medical Instrumentation (AAMI) as a Certified Industrial Sterilization Specialist (CISS), while also achieving CISS specialization in radiation. As described by AAMI, “an industrial sterilization specialist is a person who understands the principles of sterilization process development, validation, control, and management as part of the manufacture of healthcare products.”

“Very few people in the world have these specialized sterilization credentials,” said Stephen M. Perry, Chief Executive Officer and Founder of Kymanox. “Shaun’s recognition from AAMI is a further testament to our commitment to stay at the forefront of sterilization technology and to best serve our clients, who are developing tomorrow’s medicines.”

Nicholas Ciccarelli, Executive Vice President of Development at Kymanox and also a cofounder of NEUMA stated, “Our new breadth of offerings shows our commitment to early-stage innovation while moving technologies rapidly toward commercialization. Verifying device requirements through formal performance testing is a major milestone for combination product and medical device programs. Our goal is to guide our customers though early product design and later stages of product development to setup their programs for successful regulatory submissions.”

Ciccarelli, who now leads the Development team at Kymanox, oversees an integrated design and development team experienced in Medical Device and Combination Product innovation, including specialized teams focused on Device Design, Iterative Prototyping, Electrical Engineering, Sterilization Engineering, Device Feasibility & Design Verification Testing, Product Development Strategy Integration, Emergency-use Device Reliability, In Vitro Diagnostics, and Software as a Medical Device (SaMD).

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

“It’s exciting to be one of the first two hospitals in Europe to use Stryker’s Mixed Reality Guidance System,” said Professor Berhouet. “I am also pleased to be leading a pilot study to investigate the safety and effectiveness of this new technology, alongside three other centres in France.”
The KnowU incorporates the sensor that the Company plans to submit to the FDA for clearance. This proprietary sensor has been tested and proven stable and accurate in the lab setting. It was included in the Company’s prototype to validate stability outside of the lab, and is now miniaturized and wearable.
The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy