Quality Assurance and Regulatory Affairs 

Medical Device Consulting
Quality & Regulatory Compliance Management

Outsourcing

  • Temporary or "as needed" consulting for QMS compliance and regulatory affairs.

  • Internal and Supplier Quality Audits

  • CAPA System Oversight and Management

  • Monitoring quality metrics and key performance indicators for
    Management Review

  • Quality System and other training as needed

  • Complaint Handling and Adverse Event Reporting

  • Document control and maintenance of the quality system.

  • Responding to FDA 483 Observations, Warning Letters and Notified Body audit findings.

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.