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Strategic Regulatory Solutions, Inc.

Contact: Gustavo Korbin, 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, President is a Notified Body and Auditing Organization (MDSAP) auditor and RAPS certified (RAC) regulatory professional with 40 years of experience in medical device quality assurance, regulatory compliance and regulatory affairs. References are available upon request.


Years in business: 20


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