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Strategic Regulatory Solutions, Inc.

Contact:  Gustavo Kobrin, President
Specialty: Devices

Provides the following services:

Regulatory Affairs

  • Domestic and international product registrations (IDE, PMAS, 510(k), CE, CMDR)
  • Product development support

Quality Assurance

  • Quality System development
  • Internal and Supplier Audits
  • Product recall management
  • Interface with regulatory agencies
  • Corrective action management (483, warning letter, and other regulatory issues)


Gustavo (Gus) Kobrin is a Notified Body auditor and RAPS certified (RAC) regulatory professional with 32 years of experience in medical device quality assurance, regulatory compliance and regulatory affairs. References are available upon request.

 

Years in business: 14

 

   714-679-6259
   
   This email address is being protected from spambots. You need JavaScript enabled to view it.
   strategicregulatory.com 

 

 

 

 

 

 

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