Teleflex Medical OEM Announces In-House Regulatory Support Services

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
• Canada Medical 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.

(June 2011)