Known for decades of silicone and elastomer manufacturing, QMD is a global medical-device contract manufacturer serving OEMs. It helps customers bring single-use medical devices from development into production, with support that extends through regulatory and quality requirements.
ISO 13485:2016
certification
ISO 9001:2015
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ISO 14001:2015
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ISO 14001:2018
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ISO 45001:2018
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21 CFR Part 820
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FDA Medical Device Manufacturer Registration
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ISO 14644 Cleanroom Standards
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ISO 10993
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ISO 11607
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ISO 14971
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ISO 11135
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ISO 11137
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USP 23 Class VI
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CE Marking under MDD 93/42/EEC
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FDA 510(k) Clearance
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EMDR 2017/745 QMS
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EU MDR 2017/745
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SILIKON TechnologiesFounded in 2014 from the medical molding expertise of sister company Polymer Conversions, Orchard Park’s SILIKON Technologies makes precision liquid silicone rubber components, with a primary focus on medical applications. Its scientifically documented molding processes support qualification and validation work, while Class 7 and Class 8 clean-room options accommodate projects that require controlled environments. The company operates under quality management systems registered to ISO 13485 and ISO 9001.HAMBURG, NY
Quality Tool & Die / QTD PlasticsFounded in 1977, Quality Tool & Die began as a tool-and-die and precision machining shop and has grown into a contract manufacturer that builds molds and produces plastic-injection-molded components, with QTD Plastics focused on medical devices since 2014. Its in-house toolmaking and molding operations support projects from mold development through validated production, and the company is FDA registered for medical-device manufacturing. Tooling and machining are certified to ISO 9001:2015, while injection molding operates under ISO 13485:2016.MEADVILLE, PA
QosinaFounded in 1980 from entrepreneur Stuart Herskovitz’s guest bedroom, Qosina supplies OEM single-use medical device components to medical, pharmaceutical and biopharmaceutical companies. From its Ronkonkoma headquarters, the company offers more than 5,000 stock components, complimentary samples and product-development support for sourcing or adapting parts to a customer’s design. Its facility is certified to ISO 13485, ISO 9001, ISO 22301, ISO 45001 and ISO 14001 standards.RONKONKOMA, NY
Molded Devices IncFounded in California in 1963, Molded Devices Inc. develops and manufactures custom plastic and rubber components for medical, industrial, energy, aerospace and defense OEMs. Its unusual breadth comes from combining a dedicated engineering and design facility with molding, extrusion, clean-room production and assembly across a multinational manufacturing network. MDI’s Tempe injection operation traces back to a custom molding and mold-making business founded in 1966, and includes a 40,000-square-foot facility with ISO 9001:2015 and ISO 13485:2016 certification.SELLERSVILLE, PA