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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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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 United States Phone: 714-679-6259 Fax: Email: gk@strategicregulatory.com
Gustavo Kobrin President gk@strategicregulatory.com