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Medical Device Industry

 

 

 

 

Strategy

Customized Analyses and Recommendations to Meet Your Regulatory and Communications 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


Management

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

  • strategy

  • submissions

  • employee oversight

  • regulatory compliance


Deliverables

  • Experience with 510(k), PMA, IDE, and INDs

  • UDI System Strategy & Management

  • Post-Market Surveillance

  • Coordination of International Recalls

  • Establishment and maintenance of CE Marks (Tech File and Clinical Evaluation Reports)

  • Labeling

  • Device Training Materials

  • Ad Copy Review


Additional Services

  • Risk management

  • Inspection and Certification Preparation

  • Regulatory planning

  • International Recall Coordination

  • Remediation Planning and Execution

  • Corporate and Stakeholder communications