we are chalgren enterprises

 

Trusted US Based manufacturer of leadwire assemblies for the Global medical device industry.  Whether a standard or customer-specified product, our strict attention to detail assures full compliance to product specifications from raw material to finished goods. 

Capabilities / Services

Design & Development

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.

 

 

Product Validation

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.

Sterilization Services

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.

Assembly

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.

Packaging

The packaging process maintains cleanliness and prepares products for sterilization with our third-party partner.

Chalgren Products

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