RALEIGH, N.C.Teleflex Medical OEM, a full service medical product development and outsourcing business, announces the availability of in-house regulatory support services for the licensing and registration of medical products. A dedicated regulatory team can assist clients, from startups to global companies, with the overall planning and execution of regulatory compliance through all phases of a product’s life cycle. The unique, OEM-specific skills of the experts on the Teleflex Medical OEM regulatory team has lead to an extensive record of successful approvals with regulatory agencies across the world.
Teleflex Medical OEM’s regulatory services include:
- 510(k) submission for FDA clearance
- STED – Summary Technical Document Preparation
- EU Technical File for CE Marking Approval
- CanadaMedical Device License Approval and Registration
- International Device Approvals, Licensing and Registration
In addition, Teleflex Medical OEM can provide labeling review and support for claims in marketing collateral.
For additional information, visit www.teleflexmedicaloem.com.
ABOUT TELEFLEX INCORPORATED
Teleflex is a global provider of medical products designed to enable healthcare providers to protect against infections and improve patient and provider safety. The company specializes in products and services for vascular access, respiratory, general and regional anesthesia, cardiac care, urology, and surgery.
Teleflex Medical OEM provides product development and outsourcing services, including the design, engineering, regulatory, prototyping, manufacturing, packaging, and assembly of medical products, which include surgical instruments, extrusion, performance fibers, sutures, and other specialty products. The Teleflex Medical OEM family of brands includes BEERE MEDICAL®, DEKNATEL®, KMEDIC®, SMD®, and TFX OEM®.
Teleflex Incorporated (NYSE:TFX) has annual revenues of approximately $1.9 billion and serves healthcare providers in 140 countries. For detailed information, see www.teleflex.com.
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