OPTIM Associates, Inc.

Regulatory and Performance Solutions for Safe Medical Devices

Risk Management, Reliability and Quality Assurance Solutions for the Medical Device and Pharmaceutical Industries.


Regulatory Compliance

  • Quality Systems Development
  • 483 Response
  • Warning Letter Response
  • Concent Decree
  • Import Detention
  • Corrections or Removals / Recalls
  • Medical Device Reporting / Vigilance
  • Auditing
  • Training

Product Development

  • Design Controls
  • Risk Management
  • Reliability
  • DHF / DMR Documentation
  • Project / Program Management

Regulatory Submissions

  • 510(k) / Premarket Notification
  • Technical File / Design Dossier



OPTIM Associates, Inc. 
PO Box 1006 Office:  +1 (877) FDA-RISK 
859 Sanctuary Drive Office:  +1 (877) 332-7475
Suite 201A Mobile:  +1 (847) 707-7560
Lake Villa, IL  60046 Fax:  +1 (847) 265-0870 
U.S.A. information@optimcorp.com 

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