Noblitt & Rueland
- Details
- Parent Category: Resources
Contact: Brent Noblitt, Senior Partner
Specialty: Devices, IVDs, Biologics/Biotechnology
Noblitt & Rueland, for over 20 years, has been a leading medical device consulting and training firm specializing in technical FDA & international regulatory issues. All of our staff members have considerable specialized expertise and years working on medical device issues. Please contact us for a quote or more information on any of our services.
Consulting Services (assistance & audits):
- Quality Systems & Audits (FDA & ISO 13485)
- Submissions (510(k)s, CE Marks & Technical Files/Dossiers, IDE, PMAs)
- Risk Management including ISO 14971
- Design Control
- Software Compliance & Development
- Software Verification & Validation
- Medical Device Safety IEC 60601 (2nd & 3rd Edition)
- Electronic Recordkeeping & Signatures (Part 11)
In-house Training Topics:
- Design Control, the FDA & ISO
- Risk Management, ISO 14971 and FDA Requirements
- FDA Quality System Regulation (QSR/GMP) & Inspections
- Auditing Quality Systems: for FDA & ISO Compliance
- Software, the FDA & ISO
- Software Verification & Validation Strategies
- FDA Electronic Recordkeeping & Signatures
- 510(k) Submissions: Getting to Market
- CE Marking Devices & IVDs
- IEC 60601-1: Medical Device Safety Requirements
- ISO 13485:2003 Implement & Maintain
- Strategic Sales & Marketing of Medical Devices in Europe
Years in business: 20+
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949-398-5222 |
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949-398-5223 |
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www.fdaconsulting.com |