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Peak Performance Gets ISO 13485:2016 and 9001:2015 Certifications

Toll and custom compounder gets certified less than a year after it produced its first pellet.

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Peak Performance Compounding  Inc. has obtained ISO 13485:2016 (medical) and 9001:2015 (industrial) certifications, the Leominster, Mass. compounder has announced.

The founders launched the company in October 2019 to offer a service-oriented option for companies looking to fill their compounding requirements. Peak offers pre-colored high quality, specialty and unique engineered products to the medical and industrial markets. It utilizes twin screw technology for processing a wide range of thermoplastic compounds, highly filled products, and precision compounds. Also, Peak offers toll processing and custom formulating capabilities for custom coloring with customer specified ingredients for a wide range of applications.

Peak also offers pellet- or- dry-powder blending, pellet pulverizing, desiccant drying and material testing. Peak is currently working towards making its medical production area humidity- and- temperature-controlled in Leominster.

Peak says the implementation of ISO 13485:2016 and 9001:2015 certifications was rigorous. The compounder worked over the course of eight months to implement these ISO processes and procedures from scratch with the help of consulting firm Cunningham & Associates. “It was very important to me that we build this business with a culture of quality first and supreme attention to detail. Implementing ISO standards from the very beginning creates a foundation for Peak to grow within these high-quality standards,” says Todd Marchand, Peak president. “ISO is now embedded in Peak’s DNA. I am very proud of what our team has accomplished in getting these certifications in place.” 

Marchand sees high growth potential for Peak, as it will be filling a need for custom medical/industrial tolling and compounding, with a strong focus on its customer’s requirements. “The medical and high-end industrial markets will be our focus. We will offer a service-based compounding option with no minimum run sizes.”

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