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.