RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Strategic Regulatory Solutions, Inc.
About US:

Strategic Regulatory Solutions, Inc. (SRS) provides Quality Assurance, Regulatory Compliance and Regulatory Affairs consulting services to the medical device design and manufacturing companies of all sizes. SRS specializes in device regulations of the European Community, Canada and USA. Our services include domestic & international product registration strategies and submissions; QMS system installation and enhancement, product development team assistance; internal and supplier audits; regulatory inspection management; product recall management; llitigation support and QMS training. Mr. Kobrin, President and principal consultant, has over 40 years of experience in the Medical Device industry. He is a certified Notified Body and MDSAP lead auditor.

Web Site: www.strategicregulatory.com
Address:

25108 Marguerite Parkway, Suite A-354
Mission Viejo, California 92692
United States
Phone: 714-679-6259
Fax: 
Email: gk@strategicregulatory.com

Contact:

Gustavo Kobrin 
President 
gk@strategicregulatory.com

Geographic Areas: Europe
North America
Canada
Latin America
Business Type: Consulting Services
Quality Assurance
Audit/Inspections
Training/Education
Products: Medical Devices
Class I
Class II
Class III
Professional Responsibility (Regulatory Process): Quality System (QS)
Postmarket Surveillance 
Good Manufacturing Practice (GMP)
Investigational Device Exemption (IDE)
Premarket Approval (PMA)
Premarket Notification (510k)
Registration Establishment
Labeling
Postmarket Surveillance
Research and Development
Submissions/Registrations
Other Professional Responsibility: Crisis Management/Risk Management
Management
Negotiation
Strategic Planning
Training/Education