The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
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.
25108 Marguerite Parkway, Suite A-354
Mission Viejo, California 92692
|Professional Responsibility (Regulatory Process):
||Quality System (QS)
Good Manufacturing Practice (GMP)
Investigational Device Exemption (IDE)
Premarket Approval (PMA)
Premarket Notification (510k)
Research and Development
|Other Professional Responsibility:
||Crisis Management/Risk Management