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Noblitt & Rueland

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