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Consulting Services

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Noblitt & Rueland offers professional consulting services to the Medical Industry specializing in FDA and international regulatory compliance issues. The company is highly regarded for manufacturers achieve Medical Device regulatory compliance and clearance or approval of successful submissions. Services include:

• GMP/QSR/ISO Audits, Gap Assessments, Consulting & Implementation
• Independent Software Verification & Validation
• Independent Software Compliance Implementation, Audits & Assessments
• Electronic Recordkeeping-Part 11 Compliance Audits, Training & Consulting
• Design Control Implementation, Audits & Assessments
• Risk Assessment & Hazard Analysis Consulting
• Software Testing Services
• Software Quality Assurance & Documentation Services
• Complete 510(k), IDE, PMA & CE Mark Submissions
• Software Section preparation for 510(k), IDE, PMA & CE Mark Submissions
• IEC 60601-1 Medical Device Safety Consulting
• Software & Product Development
• Strategic Sales & Marketing of Medical Devices in Europe

FDA & ISO QUALITY SYSTEM CONSULTING

• Quality System Audits & Gap Assessments
• QSR/GMP-21 CFR Part 820, ISO 13485:2003, ISO 9001:2000
• QSIT Subsystems Assessment including Design Control & Risk Management
• Software Quality Assurance
• FDA Enforcement assistance, i.e. Warning Letters, 483s, etc.
• In-house Training

PRODUCT/SOFTWARE DEVELOPMENT

• Product/Software Design
• Product/Software Development
• FDA & ISO Design Control Requirements Compliance
• Small Microcontroller Projects to Large Multiprocessor Systems

ELECTRONIC RECORDKEEPING & SIGNATURES (21 CFR PART 11)

• 21 CFR Part 11 Audits & Gap Assessments
• Electronic Recordkeeping Strategic Consulting including vendor assessments
• FDA Enforcement assistance, i.e. Warning Letters, 483s, etc.
• In-house Training

TECHNICAL REGULATORY CONSULTING

• Software Development
• Software Quality Assurance
• Hazard Analysis/Risk Assessment
• Design Control
• Software Verification & Validation
• Software Quality Assurance
• Risk Management/Risk Assessment/Hazard Analysis
• IEC 60601-1 Medical Device Safety Consulting

SOFTWARE QUALITY ASSURANCE

• Software Compliance Assessments
• Software Verification & Validation Activities
• 510(k) Assistance and Software Sections
• Software V&V Planning
• Software V&V Testing
• Reverse Engineering
• Software Development Process Definition
• Software Quality Assurance Planning
• In-house Training

RISK & HAZARD ANALYSIS CONSULTING

• Risk Management & Assessments
• Hazard Analysis
• Fault Tree Analysis (FTA)
• Failure Modes & Effects Criticality Analysis (FMECA & FMEA)
• ISO 14971 Implementation & Assistance
• In-house Training

DESIGN CONTROL CONSULTING

• Product Development Assessments
• Product Development Process Definition
• In-house Training

CLIENT SUCCESS STORIES

• Rapid FDA Regulatory Submission Approvals- 510(k) - PMA - IDE
• Complaint FDA GMP Inspections
• Successful Response to FDA 483 and Warning Letters
• ISO 13485 and 9001 Certifications

TYPICAL PRODUCT EXPERIENCE

- Defibrillators - Implantable Defibrillators - Humidifiers / Respirators - Infusion Pumps - Pharmacy IV Bag Mixing Systems - Lasers / Light Activated Drugs - Laparoflators - Endoscopic Cameras - Hemapheresis Systems - Clinical Chemistry Analyzers - Immunoassay Analyzers - Microbiology Analyzers - Pelvic Muscle Stimulators - Orthopedic Surgery / Electro- Mechanical Tools - Oxygen Saturation Monitors - Cardiac Output Computers - EKG Monitors / Chart Recorders - Cardiac Imaging Systems - Cancer Detection System Software - Radiation Therapy Treatment Planning Software - Medical Image Transmission Software - Lab Information System - Host Computer Interface Software - Manufacturing Process - Neurocybernetic Implants - Manufacturing Process-Reagent packaging

EXPERIENCE

• Clients Worldwide
• Start-ups to Fortune 500
• FDA & ISO Compliance
• Submissions- 510(k), PMA, IDE
• Class I, II, & III
• Diagnostic & Therapeutic Devices
• References & Curricula Vitae Available
• Members of IEEE, AAMI, ASQ, RAPS, OCRA

PAST CLIENTS OR STUDENTS:

Small representative sample: Advanced Cardiovascular Systems/Alcon Labs/Allergan Medical Optics/Ansell/American Red Cross/Baxter Healthcare Corp./Baxter Healthcare-Microscan Div./Beckman Instruments Inc./Boehringer Mannheim/C.R. Bard Divisions/California Dept. of Health Services/COHERENT/Cordis Corp./Cardiogenesis/Dade International/Eastman Kodak/EP Technologies Inc./Hall Surgical/Heartstream/Hill-Rom/Hollister/Hudson RCI/Abbott Laboratories/Integrated Surgical Systems/Intermedics/Johnson & Johnson/Lifescan Inc./McGaw Inc./Medtronic Cardiopulmonary/Medtronic Inc./Ortho Diagnostic Systems Inc./Philips Ultrasound/Physio-Control Corp./Siemens Pacesetter Inc./Underwriters Laboratories (UL)/U.S. FDA/U.S. General Accounting Office.