QMR, LLC - Quality Management Resources

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 info@qmr-llc.com
760-451-6306
fallbrook, CA


QMR, LLC provides Quality Management and Regulatory Consulting Services including for ISO 9000/13485, FDA Compliance Consulting, Product Submissions, FDA 483/Warning Letter Responses, Quality Assurance and Management, Quality Systems Certification, Training and Vendor Sourcing.


SERVICES OFFERED

  • Conduct Medical Device Data Systems (MDDS) Assessments
  • Conduct Audits and Implement Corrective and Preventive Actions
  • Conduct Risk Assessments
  • Clinical Trial Design, Implementation and Monitoring
  • Review and Trend Complaints, Adverse Events, Recalls and MDRs
  • Prepare Responses to FDA 483s and Warning Letters
  • Review Electronic Records & Signatures
  • Implement Document and Change Controls
  • Implement Design Controls, Hazard Analysis, Risk Management and Human Factors Engineering
  • Manage ISO Registration including Registrar Selection
  • Develop or Re-engineer Quality Management Systems, Standard Operating Procedures and Quality Manual
  • Act as Management Representative
  • Prepare Submissions - 510(k), PMAA, pre-IDE, de novo, CE Mark, Canadian
  • Develop Software Development Lifecycle and Quality Programs
  • Conduct Process Mapping
  • Implement Purchasing and Supplier Controls
  • Conduct Supplier Audits
  • Conduct Training and Team Building
  • Prepare Facility Registrations and Device Listings
  • Prepare Annual Reports
  • Healthcare IT Regulatory Services - Medical Device Data Systems, Mobile Medical Apps, IEC-80001, HIPPA



QMR, LLC provides Quality Management and Regulatory Consulting Services including for ISO 9000/13485, FDA Compliance Consulting, Product Submissions, FDA 483/Warning Letter Responses, Quality Assurance and Management, Quality Systems Certification, Training and Vendor Sourcing.

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