QMR, LLC - Quality Management Resources

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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, Assessments, Audits, Training and Vendor Sourcing.

Clients Include

PatientSafe Solutions, San Diego, CA
Sun Biomedical Laboratories, Blackwood, NJ

MedApps, Scottsdale, AZ

Cranial Technologies, Tempe, AZ

Sensys Medical, Chandler, AZ

Sage Products, Cary, IL

Akorn Pharmaceuticals, Decatur, IL

Wyeth Pharmaceuticals, Rouses Point, NY

Gen-Probe, San Diego, CA

Kleen Test Products, Port Washington, WI

Abbott Laboratories, North Chicago, IL

Amicas Medical, Boston, MA

Wyndgate Technologies, El Dorado Hills, CA

ASP Division of Johnson & Johnson, Irvine, CA

Gambro Renal Products, Opelika, AL

Gambro Renal Products, Lakewood, CO

LifeSouth Community Blood Centers, Gainesville, FL

Hill-Rom, Batesville, IN

MAK Systems, Paris France

PADT, Tempe, AZ

Pegasus, San Diego, CA

DLMS, Scottsdale, AZ

Confidential, El Paso, TX

Getinge, Copenhagen Denmark
QAD, Santa Barbara, CA
Siemens, Ann Arbor, MI
Abbott Informatics, Lake Forest, IL
Kowa Optimed, Torrance, CA
HemaSoft, Madrid, Spain
GlobalMedia Group, Scottsdale, AZ

Projects Include

  • Conducted MDDS device classification assessments for ten software products.

    Implementing QMS for healthcare informatics company with handheld user interface.

    Conducted device classification assessment for innovative spinal surgery software tool.

    Prepared 510(k) submission for cardiac monitoring reference tool.

    Long-term quality system re-engineering project for medium size medical device manufacturer, performing audits and corrective/preventive actions. Ongoing validations and IT infrastructure qualification.

    Performed all QA/RA functions for multi-plant, system-wide SAP implementation and validation.

    Prepared 510(k) submission for dental materials.

    For almost four years, acted as Director of QA/RA and management representative for pre-production designer of non-invasive glucose measurement instrumentation.  Prepared PMA submission, ISO and MDD/CE requirements.  Re-engineered quality system.  Headed human factors engineering and design risk management. Assisted in assessment, evaluation and selection of contract designer and manufacturer.

    Prepared pre-IDE, 510(k) and de novo submissions, re-engineered quality system, managed efforts to correct Warning Letter deficiencies, ongoing audits and other projects.

    Prepared 510(k) submissions for Patient Wellness System and implemented QSR processes.  Assisted in assessment, evaluation and selection of contract manufacturer (electronic).

    Implemented process, equipment and software validations for start-up fully automated renal dialysis filter manufacturing facility.

    Conducted full QSR audit and implemented corrective actions. Trained all employees on QSR and procedures.  Prepared two 510(k) submissions. Assisted in assessment, evaluation and selection of contract manufacturer (Maquiladora).

    Re-engineered validation processes and serviced as Acting Director of Validation for medium sized pharmaceutical manufacturer.  Responsibilities included personnel/project management, SOPs, Validation Master Plans, Validation Protocols (development, execution and reports) for products, processes, facilities, equipment, instrumentation, test methods, laboratory, lyophilization, packaging, sterilization and contractors.

    Developed and executed assessments, SOPs, validation plans, protocols and reports for an environmental monitoring information system including 21CFR11 requirements.  Performed annual product evaluations, including evaluations of manufacturing and laboratory investigation reports.  Conducted equipment/process equivalency studies. Performed various manufacturing equipment qualifications and validations.

    Developed SOPs, MVPs, protocols and executing validations for information systems and computer controlled automated equipment, systems, utilities and processes for biologic and blood diagnostic products.  Validation requirements include 21CFR11.

    Developed operating SOPs, and developed and executes validation protocols for PLC controlled automated equipment and processes and for building/equipment cleaning and sanitation for OTC pharmaceuticals.

    Software, information system, process, equipment and electronic data/signature validations, including IQ, OQ and PQ, for diagnostic products. 

    Conducted regulatory strategy and due diligence for the possible acquisition of various types of medical technology, including combination products.

    Prepared a 510(k) gap analysis and final review of blood bank donor information system 510(k).

    Prepared a 510(k) submission for a power assisted hospital stretcher.

    Prepared a 510(k) submission for the addition of RF wireless technology to a blood bank donor information system.

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