Design & Development
Bio-potentials, or the electrical signals detected and analyzed from nerve endings within muscle tissue, have proven to be a valuable tool in diagnosing and treatment myriad human ailments. The effectiveness of this process depends on high-quality, subdermal needle electrodes, and surface electrodes.
Our production managers have been with the team for over 35 years and continue implementation of new design and development processes as technology and the market continue evolving. Chalgren complies with all local, state and federal regulations pertaining to environmental safety.
We eliminated harmful plastizers such as Di(2-ethylhexyl) phthalate (DEHP) and bisphenol A (BPA) from our processes and raw materials, while maintaining our reputation of having the finest quality electrodes in the industry.
We are always open to designing and developing new products and listening to your ideas thereof. Our industry is highly regulated. Thus there are procedures that must take place before the design and development process begins for new products. We are happy to brainstorm ideas and come up with the necessary steps, including costs, to develop the products you need.
All of our products are verified and validated pursuant to International Organization of Standards (ISO) quality management systems. We are ISO 13485 certified and also adhere to the FDA’s Current Good Manufacturing Practice (cGMP) standards. We are constantly analyzing and monitoring the actions of our competitors to ensure we’re always several steps ahead of others in the industry.
Economic trends in the United States point to certain growth in demand for neurodiagnostic components and accessories. We are concentrating on expanding sales in South America, Canada, South Korea, and Europe. It’s essential to be up-to-date on regulatory changes across the globe. We’ll also continue developing new products for our white label clients. Design qualification (DQ) and performance qualification (PQ) procedures are exhausted with every new product design to ensure our clients are getting exactly what they want.
Our electrodes are sterilized by one of the leading sterilization labs in the world. In most cases we sterilize with Gamma radiation. Microorganisms that present potential risks of infection are eradicated by the Gamma process. Our products are sterilized after packaging and they are validated sterile for up to three years thereafter. No quarantine is required and products are safe to handle immediately following the process.
Chalgren Enterprises has evolved our processes over 50 years beginning in the kitchen of our founders, to today having ISO-compliant clean rooms and industry-leading quality control standards. All production personnel undergo extensive training that covers every stage of the assembly process. This includes coating our electrodes with polytetrafluoroethylene (PTFE), validated assembly processes, and preparation for packaging.
Our products are assembled at our facility in Gilroy, California. We pride ourselves on being an American company that builds its products right here in the USA.
Each of our surface and needle electrodes is individually packed and sealed. The packaging process maintains cleanliness and prepares products for sterilization with our third-party partner. Our clients receive sterile products quickly and ready for use.