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Together they characterize the general extension and execution of the quality administration framework. You should begin creating documentation including quality strategies, quality targets, and quality manuals, beginning with the executives backing and characterizing client necessities for the QMS.
#ISO 13485 2015 ISO#
If you would like more information about this topic, please contact Todd Marchand at 97 or Please visit us at reception of the ISO 13485 standard gives a functional premise to makers to conform to the EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR), and different guidelines and shows a guarantee to the wellbeing and nature of clinical gadgets. Peak Performance Compounding, Inc has a technical staff dedicated to meeting its customer needs from toll processing to custom formulations and everything in between. We will offer a service-based compounding option with no minimum run sizes.” “The Medical and high-end industrial markets will be our focus.
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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. I am very proud of what our team has accomplished in getting these certifications in place.” President, Todd Marchand Implementing ISO standards from the very beginning creates a foundation for PEAK to grow within these high-quality standards. “It was very important to me that we build this business with a culture of quality first and supreme attention to detail. The PEAK team worked diligently over the course of eight months to implement these ISO processes and procedures from scratch with the help of consulting firm Cunningham & Associates. The implementation of ISO 13485:20:2015 certifications was a very rigorous process. Peak is currently working towards making their medical production area humidity and temperature-controlled in Leominster, MA – the Pioneer Plastics City of America.
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In addition to twin screw compounding, Peak also offers pellet or dry powder blending, pellet pulverizing, desiccant drying and material testing. Also, Peak offers toll processing and custom formulating capabilities for custom coloring with customer specified ingredients for a wide range of applications. Peak offers twin screw technology that allows for processing a wide range of thermoplastic compounds, highly filled products, and precision compounds. Peak offers pre-colored high quality, specialty and unique engineered products to the Medical and Industrial markets. The founders launched the company to offer a service-oriented option for companies looking to fill their compounding requirements. LEOMINSTER, Mass – Specialty Medical and Industrial compounding and tolling company, Peak Performance Compounding, Inc, ( who started manufacturing in October 2019 obtains ISO 13485:2016 (Medical) and 9001:2015 (Industrial) certifications. ISO certifications achieved for toll processing and formulation of thermoplastic compounds for the medical and industrial markets.