U.S. FDA & International Medical Device Consulting and Training Services
Noblitt & Rueland (N&R) is a 20+ 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, auditing, software development, software verification & validation, software quality assurance, risk/hazard management, design control, biocompatibility, electrical safety, electrical interference, submissions (e.g. 510(k) & CE Marking), etc. As opposed to the services of a sole consultant working on their own; 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 assigned consultant in providing a sounding board for ideas, strategies, and thoughts regarding and throughout a project. As the project progresses, if it is thought that 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.
Contact us at: info@fdaconsulting.com We will be happy to discuss your project with you.
Services include:
FDA & ISO QUALITY SYSTEM CONSULTING
SUBMISSIONS
RISK & HAZARD ANALYSIS CONSULTING
DESIGN CONTROL CONSULTING
SOFTWARE QUALITY ASSURANCE
ELECTRONIC RECORDKEEPING & SIGNATURES (21 CFR PART 11)
ELECTRICAL SAFETY & COMPLIANCE
TECHNICAL REGULATORY CONSULTING
PRODUCT/SOFTWARE DEVELOPMENT
CLIENT SUCCESS STORIES
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
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