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+353 (0)1 893 4961


Quality & Regulatory

Teleflex's proven experience in the licensing and registration of medical products can help you achieve success in today's challenging regulatory environment. Wherever you are in the world, Teleflex's global regulatory capabilities will ensure that your product is compliant.

Your partner for regulatory excellence

With increasingly strict regulations facing the medical device industry, keeping up on quality control and compliance can be challenging and costly. Fortunately, Teleflex’s extensive, global regulatory expertise and proven track record of successful approvals, ensures that it is perfectly placed to deliver full-service regulatory support from submission to clearance.

Our commitment to regulatory excellence provides value-added service to ensure that your intranasal drug delivery device or component will be in compliance with local and global regulatory guidelines through all phases of the product lifecycle.

As your regulatory partner, we will prepare and submit a review package that is well researched We can also provide sustaining support and regulatory assessment for impact of a product change.

Core competencies

  1. 510(k) submission for FDA clearance
  2. STED – Summary Technical Document Preparation
  3. EU Technical File for CE Marking Approval
  4. Canada Medical Device License Approval
  5. International Device Approvals, Licensing and Registration

 

 

Our services

To discuss how Teleflex could help you achieve your regulatory objectives, contact us.

Planning and execution of regulatory compliance
  • Regulatory experts constantly monitor the changing national and international regulatory environments
  • Expertise in the planning and execution of regulatory compliance through all phases of the product life cycle
Comprehensive regulatory strategy development
  • Audit of regulatory approval options, approaches and risks based on specific assumptions regarding the product and regulatory environment
  • The strategy will provide detailed information about regulatory requirements, schedules and fees
Submission support and approvals
  • Full-service regulatory support from submission to clearance and routine sustaining product support, which includes medical device registration, and certifications and/or approvals
Data preparation and presentation
  • Preparation and submission of a review package that is well researched, focused and will present your product as clearly and effectively as possible to the regulatory agency
  • OEM documentation to support: product master files, Declaration of Conformance to Standards, safety sheets or certificates of analysis and technical and regulatory information
Documentation for labelling and promotional claims
  • Labelling review and support for claims in collateral and literature

Contact us

Why Teleflex for OEM?

Teleflex is a global provider of medical devices with over 20 years’ experience servicing OEM partners with bespoke device requirements. As a full-service provider, Teleflex delivers all the product development and production services you need to get your ideas off the drawing board and into the market.

We have the extensive expertise and decades of experience in delivering innovative solutions for your toughest, new product challenges. That is why we are the “go to” people for OEMs worldwide who want to partner with a true leader in custom-engineered products. In choosing to work with Teleflex as your intranasal drug delivery partner, you can be assured that your needs will be the core focus of the partnership.

Call us on +353 (0)1 893 4961 or get in touch