WORK WITH THE REGULATORY EXPERTS™

Regulatory Services Tailored to Your Needs

• Teleflex Medical OEM has proven experience in the licensing and registration of medical products according to international standards. Depending on the product, target market, and requirements profile, we can help bring your product to market.
• Teleflex Medical OEM has an extensive record of successful approvals with major regulatory agencies across the world.
• Regulatory experts on staff monitor the constantly changing national and international regulatory environments.
• We can provide expertise in the overall planning and execution of regulatory compliance through all phases of the product life cycle.

Comprehensive Regulatory Strategy Development

• The development of a regulatory strategy will include the assessment of regulatory approval options, approaches, and risks based on specific assumptions regarding the product and regulatory environment. In addition, the strategy will provide detailed information about regulatory requirements, schedules, and fees.
• The regulatory team at Teleflex Medical OEM will keep a watchful eye on maintaining full compliance with national and international regulations and standards. We can provide sustaining support and regulatory assessment for impact of a product change.

Choose Teleflex Medical OEM for Expert Submission Support

• Teleflex Medical OEM offers full-service regulatory support from submission to clearance and routine sustaining product support, which includes medical device registration, and certifications and/or approvals.
• Your choice: Teleflex Medical OEM can prepare selected sections, or the complete the entire application for traditional devices and systems.
• Our regulatory team can maintain regulatory coverage, as required, for product life cycle management.
• Teleflex Medical OEM’s portfolio of services includes:
  • 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

Data Preparation and Presentation

• As your regulatory partner, Teleflex Medical OEM will prepare and submit a review package that is well researched, focused, and presents your product as clearly and effectively as possible to the regulatory agency.
• Teleflex Medical OEM can provide documentation to support:
  • Product master files
  • Declarations of Conformance to Standards
  • Safety sheets or certificates of analysis
  • Technical and regulatory information
  • Documentation for labeling and promotion claims
• Our regulatory team also provides labeling review and support for claims in collateral and literature.