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Post Approval Support

»ÆÈ˵¼º½ Post Approval Support

Monitoring the safety and effectiveness of your medical device after it has been commercialized requires the implementation of effective Post Approval Support processes. These strategies and activities are specifically designed to ensure the ongoing compliance of your product(s). Regulatory Compliance »ÆÈ˵¼º½Â® (RCA)Ìýcan help you design, implement, and execute a Post-Market Support Strategy including:

  • Corrective and Preventive Action (CAPA) Support
  • Root Cause Investigation
  • Audit / Inspection Preparation and Remediation
  • Labeling Review and Assessment
  • Post-Market Surveillance (PMS)
  • »ÆÈ˵¼º½ Reporting / Adverse Event Reporting
  • Recall Management
  • Complaint Handling
  • Re-submission Assessment and Remediation
  • Post Approval Support

Our broad range of »ÆÈ˵¼º½ Regulatory Affairs consulting services include:

Regulatory Affairs

New Product Support

IVDR
EU MDR

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To begin the Regulatory Compliance »ÆÈ˵¼º½ scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.ÌýYou may also email us at [email protected].

 

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