Ension, Inc. is a product design and development company focused on the clinical translation of medical technologies. The company says it maintains compliance with FDA design controls and ISO standards.
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Nissha Medical TechnologiesWith roots stretching back more than a century, Nissha Medical Technologies designs and manufactures single-use medical technologies, including complex minimally invasive devices and clinical wearables. The Buffalo-headquartered medical devices subsidiary of Japan’s publicly held Nissha Co. operates 10 facilities across five countries, combining product design, regulatory expertise and scalable production. It also brings more than 30 years of experience to complex cable assemblies used in critical-care procedures and holds ISO 13485 certification.BUFFALO, NY
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
IDE GroupIDE Group is an entrepreneurial medical-technology partner that designs, engineers, manufactures and commercialises healthcare products and ventures. Its cross-disciplinary team works across the full journey from problem discovery to market launch, with particular depth in regulated medtech and more than 20 years of respiratory-device experience. With ISO 13485:2016-certified operations in Australia and the Netherlands, IDE has helped bring products such as Bayer’s MEDRAD Centargo CT Injector and its own OKO ophthalmic auto-injection system toward market.NEWTOWN SQUARE, PA
Paragon MedicalParagon Medical brings more than a century of combined medical-manufacturing expertise to its work as a global contract design and manufacturing organization for medical-device companies. Its vertically integrated operations support customers from product development through commercialization, with ISO 13485:2016-compliant facilities across its worldwide network.DAYTON, OH