Consulting Services List & Info

Please either fill out a short Consulting Inquiry Form , phone 1-949-398-5222 or send an e-mail to info@noblitt-rueland.com to quickly send us an inquiry regarding your consulting needs so we may provide you with an estimate or proposal. We will be happy to discuss your project with you.

Background & Experience: Noblitt & Rueland (N&R) is a 25+ year old consulting firm that specializes in the medical device technical-regulatory market. All of our consultants have a wealth of medical device experience, most with over 20 years of experience individually. Each of our consultants has their own specialty expertise such as FDA & ISO compliance in regulatory and quality systems, submissions (e.g. 510(k) & CE Marking), auditing, enforcement issues, complaints/MDRs/Recalls, software development, software verification & validation, software quality assurance, risk/hazard management, design control, biocompatibility, electrical safety, electrical interference, etc. As opposed to the services of a sole consultant working alone; the N&R management team, having considerable experience in the industry, helps the client identify the correct N&R consulting resource for a particular project. N&R management will then work with the primary or lead consultant (if a team is needed at the onset) in providing a sounding board for ideas, strategies, and thoughts regarding and throughout a project. As the project progresses, if additional specialty expertise would benefit the client during the project, the consultant or N&R managment will discuss the option with the client and only upon client approval will engage the appropriate N&R specialty consultant. Our team approach can greatly benefit clients because projects can be completed accurately and efficiently without the risk of venturing outside an individual consultant's expertise. Logistically this is also very beneficial since the project can be usually be completed under one Purchase Order and non-disclosure agreement

Consulting Inquiry Form

Consulting Services include:

• Quality System (FDA QSR/GMP, ISO 13485/9001)
  • Implementation
  • Auditing or Gap Assessment
  • Correction
  • Improvement
  • Major Subsystems
  • Design Control
  • CAPA & MDRs
  • PAPC
  • Management Responsibility
  • UDI Implementation & Revisions to Quality System
  • Compliance/Enforcement Response- FDA-483s, Warning Letters
  • Recalls, Correction & Removal Assistance
• Submissions: 510(k), IDE, PMA & CE Mark, including:
  • 510(k) Refuse to Accept (RTF) and E-copy assistance
  • Requests for Additional information (AI) by FDA
  • MDD amendment requirements such as literature searches and clinical studies
• Design Control Implementation, Audits & Assessments/Improvements
• Risk Management & Hazard Analysis Consulting (including ISO 14971 Compliance)
• IEC 60601-1 Medical Device Safety Consulting and 3rd Edition Transistion
• Electronic Recordkeeping-21 CFR Part 11 Compliance Audits, Training & Consulting
• Software Quality Assurance & Documentation Services
• Independent Software Verification & Validation
• Independent Software Compliance Implementation, Audits & Assessments
• Software Testing Services
• Software Section preparation for 510(k), IDE, PMA & CE Mark Submissions
• Software & Product Development
• ...plus many other services...please inquire if you are looking for a specific service or specialty

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FDA & ISO QUALITY SYSTEM CONSULTING

• Quality System Implementation, Audits & Gap Assessments, MDSAP (Medical Device Single Audit Program)
• QSR/GMP-21 CFR Part 820, ISO 13485, ISO 9001
• Audits & Gap Assessments, MDSAP (Medical Device Single Audit Program)
• QS Assessment including all subsystems, i.e. Design Control & Risk Management, CAPA, PAPC, Management Responsibilty
• Compliance; Complaint Handling, Medical Device Reporting (MDRs), Recalls, etc.
• In-house Training

SUBMISSIONS

• 510(k) Creation & Submission , all or sections
• PMA Creation & Submission, all or sections
• CE Mark-Technical File/Technical Dossier Creation & Submission
• Submission Reviews
• FDA or Notified Body interaction and official contact
• 510(k) Refuse to Accept (RTF) and E-copy assistance
• FDA Requests for Additional information (AI or RAI) assistance

COMPLIANCE & ENFORCEMENT ASSISTANCE

• FDA 483 Reponse
• Warning Letter Response
• Understanding other enforcement issues and next steps
• Recall Decisions and Assistance
• Correction & Removals
• Medical Device Reporting and Complaint Handling
• In-house Training

RISK & HAZARD ANALYSIS CONSULTING

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

DESIGN CONTROL CONSULTING

• Design Control Implementation (FDA & ISO Compliant)
• Design Control Audits/Assessment
• Design Control process improvements (usually to fix bottlenecks and development delays)
• In-house Training

SOFTWARE QUALITY ASSURANCE

• Software Compliance Assessments (FDA & ISO Compliant) including IEC 62304
• 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

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

ELECTRICAL SAFETY & COMPLIANCE

• IEC 60601-1 General Requirements for Medical Electrical Equipment Safety
• IEC 60601-1-2 General Requirements for Medical Electrical Equipment Safety-Electromagnetic Compatibility
• Collateral Standards (examples):
  • IEC 60601-1-6 Usability
  • IEC 60601-1-8 Alarms
  • IEC 60601-1-9 Environmentally Conscious Design of Medical Electrical Equipment
• IEC 60601-2-XX Device Specific Standards, identification & assistance
• Standards assessement
• Design review/assessment
• Testing strategies/plans/implementation
• Test house assistance & technical negotiations
• In-house Training

TECHNICAL REGULATORY CONSULTING

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

PRODUCT/SOFTWARE DEVELOPMENT

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

CLIENT SUCCESS STORIES

• Rapid FDA & International Regulatory Submission Approvals- 510(k) - PMA - IDE - CE Marks
• Successful FDA QSR/GMP Inspections
• Successful Response to FDA 483 and Warning Letters
• ISO 13485 and 9001 Certifications

TYPICAL PRODUCT EXPERIENCE (Very partial sample list...feel free to inquire about your product)

- Defibrillators - Implantable Defibrillators - IVDs - 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: (Very partial sample list...feel free to inquire about your company)

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

Consulting Inquiry Form