Teleflex Medical OEM

Teleflex Medical OEM Announces In-House Regulatory Support Services

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 led 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 clearanceSTED – Summary Technical Document PreparationEU Technical File for CE Marking ApprovalCanadaMedical Device License Approval and RegistrationInternational 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.