Medical Device Qualified Supplier Directory

 

Noblitt & Rueland Company Profile

 

www.fdaconsulting.com/
E: [email protected]
T: (949) 398-5222 or (888) 892-4664
F: (949) 398-5223

Address
5405 Alton Pky. 5A, #530, Irvine, CA, 92604, United States
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Qualifications: Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe, Worldwide

 

Noblitt & Rueland, for over 25 years, has been a leading consulting and training firm to manufacturers in the medical device, pharmaceutical, and biotech industries. We specialize in technical FDA & ISO regulatory and quality issues including Quality Systems, Design Control, Risk Management, Software, Electrical Safety Standards, Electronic Recordkeeping & regulatory consulting for FDA & Internationally regulated medical industries.

Introduction

Noblitt & Rueland services help companies get compliant medical products on the market quickly and help companies continue to stay out of regulatory trouble. We also help companies when non-compliance or FDA enforcement issues arise. We do all of this by offering highly skilled and experienced consulting assistance; as well as, teaching training programs that meet the requirements of FDA & international regulations.In-house training seminars are offered on numerous FDA/ISO issues and are taught at your facility with all discussions held in confidence. We have listed a sampling of our consulting services and training courses below. Please note that our services can standalone or integrate seamlessly with your current RA/QA and R&D efforts.

 

Consulting / Implementation / Audit Services

Quality System (FDA 21 CFR Part 820 & ISO 13485)

Mock FDA audit / inspection

Internal Auditing

Design Control

Risk Management (ISO 14971)

Software Quality Assurance

Software Verification & Validation (V&V)

Complaint handling & Medical Device Reporting (MDR)

Submissions 510(k), PMA, IDE, CE Mark Technical File

FDA enforcement resolution & remediation (FDA 483, Warning Letter, Recalls, etc.)

Device Safety (IEC 60601-1, including collateral standards e.g. IEC 60601-1-6, IEC 60601-1-8, etc.)

 

In-house Training Courses / Seminars

FDA Quality System Regulation (QSR/GMP) & Inspections

Design Control, the FDA & ISO

Risk Management, ISO 14971 and FDA Requirements

Software, the FDA & ISO

Software Verification & Validation Strategies

FDA Electronic Recordkeeping & Signatures (21 CFR Part 11)

510(k) Submissions: Getting to Market

CE Marking Medical Devices, MDD, IVD, & AIMD

IEC 60601-1 the 3rd Edition: Medical Device Safety Requirements

Auditing Quality Systems for FDA & ISO Compliance

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Noblitt & Rueland

www.fdaconsulting.com/
E: [email protected]
T: (949) 398-5222 or (888) 892-4664
F: (949) 398-5223

Address
5405 Alton Pky. 5A, #530, Irvine, CA, 92604, United States
View map