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Medical Devices

ENABLING INNOVATION

Fueling the Future of Treatment

Compliance Insight and their expertise in Medical Device FDA Regulations has been helping the medical device industry improve global health for more than two decades.

Whether you are developing a brand new product or are refreshing an existing device, our Medical Device FDA Regulation experts will guide you through each phase of the review process. We'll leverage our decades of industry experience to facilitate FDA regulatory approval so you can bring your product to market, and ultimately: make a difference in patient care.

Select Services & Capabilities

  • Strategic Planning

  • Product Classification

  • Medical Device Reporting

  • Agency Relations

  • CMC Compliance

  • FDA Submissions

  • Monitor Submissions and Approvals

  • 510(k) Research

  • Technical Comparisons

  • Document Preparation

  • Review Testing Requirements

  • Review Applicable FDA Guidelines & Standards

  • Quality Compliance

  • Prepare & File Class Applications

  • Quality System Audits

  • Label & Advertising Review

  • Regulatory Issues

  • Risk Management

  • 510(k) Submission

  • cGMP compliance

Industry Expertise