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Global Regulatory Services |
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Global Regulatory Services
Med Surgical OEM can help you achieve success in today's challenging regulatory environment.
Regulatory Services Tailored to Your Needs
- Get the Med Surgical OEM advantage: our proven experience in the licensing and registration of medical products. Depending on the product, target market, and requirements profile, we can help bring your product to market.
- Our regulatory services are conducted according to international standards
Expert Team of Regulatory Specialists
- 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.
- Med Surgical OEM has an extensive record of successful approvals with major regulatory agencies across the world.
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.
- Our regulatory team 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.
Submission Support
- We offer 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: Med Surgical OEM can prepare sections or the complete application for traditional devices and systems.
- Our regulatory team can maintain regulatory coverage, as required, for product life cycle management.
- Med Surgical 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, we will prepare and submit a review package that is well researched, focused and will present your product as clearly and effectively as possible to the regulatory agency.
- Med Surgical 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.
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