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Professional and Successful Regulatory Submissions

A successful regulatory submission is a prerequisite for gaining market approval. Every regulatory agency has unique requirements, and those complex requirements often change. Successful submissions require explicit adherence to specific content and format requirements established by the respective regulatory authorities. Communication with regulatory authority staff members may even be necessary for a timely approval.

Our Fang consultants are specialists who understand the evolving requirements. We are experts at creating and presenting submissions for approval by worldwide regulatory agencies. Our professional regulatory team has decades of cumulative experience and is collectively responsible for hundreds of successful submissions.

Regulatory Submission Capabilities Include:

  • 510(k)
  • pre-IDE/IDE
  • PMA applications
  • de Novo
  • Technical File & Design Dossier for CE marking

Benefits:

  • Product support from concept through post-market activities
  • Ability to leverage industry best practices
  • Minimize potential product approval delays
  • Reduced likelihood of audit deficiencies or product recalls/li>

Expertise Provided

Product Development Protocols (PDP)

EU MDR Technical Documentation

Post-market Surveillance Protocols

GSPR Checklists

Labeling/Labeling Review

FDA and other Regulatory Authority Meetings

Product Team Support to Ensure Devices Meet Regulatory and Product Safety Standards

MDD to MDR Gap Analyses

Regulatory Strategy

Global Registration Guidance and Support

Standard and Guideline Reviews and Guidance

Establishment Registration and Device Listing

Regulatory Questions?

Reach out to Fang Consulting and a Consultant/Strategist will followup with you.