06.22.11
Teleflex Medical OEM, a provider of full-service medical product development and outsourcing, now will offer an in-house regulatory support services for the licensing and registration of medical products.
A dedicated regulatory team will assist clients with the overall planning and execution of regulatory compliance through all phases of a product’s life cycle.
Services will include:
In addition, the comjpany can provide labeling review and support for claims in marketing collateral.
Teleflex Incorporated has annual revenues of approximately $1.9 billion. The company specializes in products and services for vascular access, respiratory, general and regional anesthesia, cardiac care, urology, and surgery. eleflex 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.
A dedicated regulatory team will assist clients with the overall planning and execution of regulatory compliance through all phases of a product’s life cycle.
Services will include:
- 510(k) submission for U.S. Food and Drug Administration clearance;
- STED (summary technical document) preparation;
- European Union technical file for CE marking approval;
- Canada medical device license approval and registration; and
- International device approvals, licensing and registration.
In addition, the comjpany can provide labeling review and support for claims in marketing collateral.
Teleflex Incorporated has annual revenues of approximately $1.9 billion. The company specializes in products and services for vascular access, respiratory, general and regional anesthesia, cardiac care, urology, and surgery. eleflex 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.