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+

	949-398-5222
	949-398-5223
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	www.fdaconsulting.com