QUALITY

ZebraSci Inc. was founded in 2009 as a company dedicated to developing novel inspection technologies to ensure quality in parenteral packaging and combination products.  Over the years, we’ve grown into a service organization by providing scientific expertise, superior customer service and a strict adherence to client requirements.  ZebraSci now works with 100’s of medical device, pharmaceutical, biotechnology companies to help them develop combination products.  Our clients partner with ZebraSci to resolve technical issues and accelerate the “time to market” of safe and effective products.

ZebraSci, Inc. has developed and implemented a Quality Management System (QMS) to demonstrate our ability to consistently provide products and services that adhere to FDA regulations, ISO standards, and customer Quality System requirements.

The QMS at ZebraSci, Inc. is ISO/IEC 17025:2017 accredited.  We aim to comply with ISO 13485:2016 and FDA 21 CFR Part 210, 211, & 820 for all of our combination product development services.  Along with providing the highest quality inspection products and laboratory services, we will strive to continuously improve our QMS, keeping quality and compliance to applicable regulations at the core of our daily work, and to keep client satisfaction at the forefront of our business.  These core values will enable us to lead the industry.

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Want to learn more about our medical device and combination product testing and development services? Contact us below to schedule an audit of one of our sites.

Medical Device and Biopharmaceutical companies both large and small partner with ZebraSci. From entrepreneurial start-ups to Fortune 500 companies, our laboratories have the resources and technology you need for your medical device and combination product development project.

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