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EAGLEVILLE, Pa.--Inteprod LLC, a medical device developer and contract manufacturer, has received what the company says is “a major milestone” in its five-year history--an ISO 13485 Certificate of Registration. Issued by KEMA Quality B.V., the certification confirms Inteprod's “steadfast commitment to continual improvement, risk management, compliance with statutory and regulatory requirements, and complete customer satisfaction,” according to a release from the company. ISO 13485 is an internationally recognized standardization system that defines the standards for the design, development, production, and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective medical devices.
“Inteprod continually strives to be the leader in the contract development and manufacture of medical products,” said Inteprod President and Founder, Rick T. Smethers, in a statement announcing the certification. “This certification is a tribute to Inteprod’s continued focus on exceeding customer expectations, and validates our commitment to high quality standards.”
Inteprod (www.inteprod.com) is a full-service supplier of comprehensive design, development, and contract manufacturing services for products in the medical device, medical diagnostics, and food safety diagnostics industries. Its capabilities in developing and manufacturing medical products are applicable to hand-held devices, point of care diagnostics, bedside diagnostics, LOC technology, patient monitoring, analytical instruments, and minimally invasive surgical instruments. Inteprod’s services are reported to include concept development, feasibility, industrial design, safety agency approvals and compliance, testing and validation, purchasing and planning, and supply chain management. They also encompass inventory control, quality assurance, document control, in-house rapid prototyping, and customer inventory management and shipping services.
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