About Proven Process Medical Devices
Proven Process Medical Devices Inc. is one of the nation's leading designers and manufacturers of Class II and Class III medical devices. The company is an EN ISO 13485:2016 certified and FDA registered full-service outsourcing partner that offers exceptional design, development, validation and contract manufacturing services exclusively for the medical device industry.
Founded in 1994, Proven Process exists to address the unmet need for an outsourced provider to the medical device industry with the in-depth technical, quality and regulatory knowledge needed to develop and manufacture sophisticated medical products. The company founders developed a "Proven Process” combining creative, state-of-the-art R&D with exceptional design, process, and quality controls to achieve new product development and manufacturing success.
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11-50 employees
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Medical Devices
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110 Forbes Boulevard, Mansfield, MA 02048, US
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1994
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Contract Manufacturing, Product Development, Aftermarket Servicing, Customer Needs Assessment, Medical Device Contract R&D, Milestone/Cost/Metric Tracking, Multiple Partner Management, Pilot-To-Full Scale Manufacturing, Verification & Validation
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Frequently Asked Questions about Proven Process Medical Devices
James Sluetz is the CEO of Proven Process Medical Devices. To contact James Sluetz email at [email protected].
The decision makers in Proven Process Medical Devices are Brian Valentine, Charles Aubin, Dara Mcmahon, etc. Click to Find Proven Process Medical Devices decision makers emails.
Proven Process Medical Devices specializes in the design and manufacturing of Class II and Class III medical devices. This includes a wide range of products used in various medical applications, ensuring compliance with stringent regulatory standards. Their expertise encompasses both innovative product development and the production of established devices.
Proven Process provides comprehensive contract manufacturing services that include pilot-to-full scale manufacturing, milestone tracking, and multiple partner management. They ensure that all manufacturing processes meet regulatory requirements and quality standards, leveraging their EN ISO 13485:2016 certification to deliver high-quality medical devices.
Proven Process supports product development through a structured approach that includes customer needs assessment, verification and validation, and rigorous testing protocols. Their team collaborates closely with clients to understand their specific requirements and to develop tailored solutions that meet both market needs and regulatory compliance.
Verification and validation are critical processes in medical device manufacturing that ensure the product meets design specifications and intended use. Proven Process employs these processes to minimize risks, enhance product reliability, and ensure compliance with regulatory standards. This is essential for maintaining patient safety and achieving successful market entry.
Yes, Proven Process offers aftermarket servicing as part of their comprehensive service portfolio. This includes maintenance, repair, and support for medical devices post-market launch. Their focus on aftermarket servicing helps clients extend the lifecycle of their products and maintain compliance with regulatory requirements.
Proven Process Medical Devices serves a variety of industries within the healthcare sector, including surgical devices, diagnostic equipment, and therapeutic devices. Their expertise in contract manufacturing and product development allows them to cater to diverse client needs across these industries, ensuring high-quality solutions tailored to specific applications.
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