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Medical Device Regulatory Affairs

Meet the Complex Challenges of Global Regulation and Develop Strategies to Minimize Risk and Maximize Benefit

Regulatory Intelligence

Collate and analyze the latest regulatory changes and their impact on product development and registration.

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Regulatory Compliance

Establish processes and checks for compliance with mature and emerging market regulations.

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Regulatory Strategy

Enter new markets and maintain registration statuses in existing markets with our expertise in complex regulations, product nuances, and health authority engagement.

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Product Registration Support

Receive first-time-right product registration and maintenance submissions to health authorities worldwide.

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Technical Document Prep

Get complex dossier and technical file development using the latest regulatory intelligence and industry-leading best practices.

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Artwork and Labeling Services

Manage global and local labeling standards and enhance patient safety with high-quality artwork, labeling services, and flexible hybrid delivery models.

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Copy Review Development

Ensure high-quality content development following stringent regulatory requirements with help from skilled, professional reviewers steeped in regulatory intelligence.

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Change Control Management

Solve complex technical and digital change requirements and maintain an edge in global markets with fast, frustration-free medical device support capabilities.

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Publishing

Receive full support with submission processes for medical devices throughout entire product lifecycles for multiple regions worldwide.

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EUDAMED Support

Get support with EUDAMED regulatory data preparation, registration, and maintenance from ClinChoice regulatory strategists and in-country affiliates.

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