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Medical Device Regulatory Consulting

Proven Regulatory Strategies and Advice

Medical Device Regulatory Services

Market Entry

  • PMA Submissions / 510(k) Notifications

  • Global Medical Device Approval and Registration (ROW)

  • Device Registration and Listing

  • New Tech Files / Design Dossiers

  • CE Marking / European MDR Compliance

  • Health Canada CMDR Compliance and Licensing

  • Master File Preparation 

  • U.S. Designated Agent for Foreign Manufacturers

 

Market Maintenance

  • Regulatory gap assessments, quality system change/transition planning as regulations change

  • Post Launch Regulatory Support

  • Complaint Management / Adverse Event Reporting

  • Master File Maintenance

  • Tech Files / Design Dossier updates 

  • Post Market surveillance

 

Remediation

  • FDA Warning Letter / 483 Support

  • FDA Consent Decree Support

  • CE Mark reinstatement

 

Data Management Compliance

  • HIPAA-Health Insurance Portability and Accountability Act

  • HITRUST-Security for Health Information Networks

  • GDPR-General Data Privacy Regulation

  • ISO27001 (Information Security)

  • Hazardous Materials (Various laws)

Help From Start to Finish

To achieve milestones effectively, you need medical device consulting services at several checkpoints along the process. By hiring us you’ll save precious time and money along the way.

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