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Teleflex Medical OEM is a single source provider of the design, development, and production services needed to get ideas off the drawing board and into the market. Offering deep expertise and decades of experience, Teleflex Medical OEM engineers deliver innovative solutions for the toughest, new product challenges. Teleflex Medical OEM engineers are known as the go-to people for OEMs worldwide who want to collaborate with a leader in custom engineered:

• Extrusions of PTFE, FEP, EFEP, and other high-performance thermoplastics
• Diagnostic and interventional catheters
• Sheath/dilator sets (introducers) and kits
• Performance fibers
• Specialty sutures
• Bioresorbable resins and yarns

Teleflex Medical OEM can offer customers everything from raw materials to components to next-gen, finished medical devices.

Teleflex Medical OEM Delivers Global Regulatory Services:

• Proven experience in the licensing and registration of medical products
• Regulatory services conducted according to international standards
• Experts monitor the constantly changing national and international regulatory environments
• Expertise in the overall planning and execution of regulatory compliance through all phases of the product life cycle
• A watchful eye on maintaining full compliance with national and international regulations and standards
• Sustaining support and regulatory assessment for impact of a product change
• Full-service regulatory support from submission to clearance and routine sustaining product support
• Prepare sections or the complete application for traditional devices and systems
• Maintain regulatory coverage, as required, for product life cycle management
• Prepare and submit a review package that is well researched, focused, and will present the product as clearly and effectively as possible to the regulatory agency