Welcome to Strategic Regulatory Solutions, Inc.

Medical Device Regulatory Affairs and Quality Assurance Consulting Services
Gustavo Kobrin, President
Founded in 1998

SRS, Inc. provides a wide range of assistance in the fields of Quality Assurance, Regulatory Compliance and Regulatory Affairs for the medical device industry. Our goal is to help companies maintain their competitive edge through cost effective compliance and product registration strategies to help you succeed.

Quality Policy

SRS, Inc. conducts its work to ensure medical device specification developers and manufacturers achieve their goals in a manner that is compliant with applicable regulations. SRS shall provide cost effective and timely regulatory advice.


SRS, Inc. utilizes internal and external resources to meet your needs. Gustavo (Gus) Kobrin, President, has more than 30 years of experience in the medical device manufacturing industry. Mr. Kobrin has diverse, hands-on experience with international and domestic product registrations of all medical device classifications; regulatory inspections; quality system development; auditing, and project management. Gus Kobrin is a Notified Body Auditor, Certified Quality Auditor (CQA) and Certified Regulatory Affairs professional (RAC). Gus Kobrin is bi-lingual, Spanish-English.


SRS, Inc. associates are highly trained individuals with a large array of knowledge to meet your project's needs.