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.
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.”
Related Content
-
Record Reshoring Rates in 2022
Reshoring and foreign direct investment (FDI) in the third quarter marked their highest ever level, eclipsing the previous record set in the second quarter of 2022.
-
Collaboration will bring Recycled Plastic to Medical Device Packaging
Agreement between Eastman and Ethicon will put copolyester derived from recycled materials in sterile barrier applications.
-
Medical Molder, Moldmaker Embraces Continuous Improvement
True to the adjective in its name, Dynamic Group has been characterized by constant change, activity and progress over its nearly five decades as a medical molder and moldmaker.
