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Medical Device Industry

 

 

 

 

Strategy

Analyses and Recommendations to Meet Your Regulatory Needs

We provide Regulatory Planning that ensures optimization of

  • regulatory submissions

  • promotional communications

  • brand strategies

that fit your Company's specific needs for long-term regulatory compliance


Deliverables

  • 510(k), PMA, IDE, and INDs

  • Establishment and Maintenance of CE Marks: Tech Files, Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up Reports (PMCF)

  • Navigation of global device registration

  • Labeling and Promotional Review

  • UDI System Strategy & Management

  • Post-Market Surveillance

  • Global Recall Coordination


Management

We offer management of Regulatory Affairs departments with a focus on:

  • training

  • process and procedures

  • long-term regulatory compliance


Additional Services

  • Regulatory planning and long-term strategy

  • Remediation planning and execution

  • Corporate and Stakeholder communications