|
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 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
|
