U.S. FDA & International Medical Device Consulting and Training Services

Noblitt & Rueland: FDA & GMP, Design Control & Medical Device Software Consulting and Training Services


Consulting Services

Training
On-Site Training
Consulting

 

Please either fill out a 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 Services include:   Consulting Inquiry Form

FDA & ISO QUALITY SYSTEM CONSULTING

SUBMISSIONS

COMPLIANCE & ENFORCEMENT ASSISTANCE

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

Consulting Inquiry Form


Contact us at: info@noblitt-rueland.com

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