About Us Section
When start-ups and Fortune 500™ companies need help with FDA compliance in the Medical Device and Biotechnology fields, they rely on the management consulting provided by Paradigm Consulting Services, based in San Diego, California. We provide iondustry-leading and objective expertise in Quality Management Systems (QMS) development. Our array of services includes systems development, QMS implementation activities, non-compliance remediation and audit services all from one central and trusted source. We work with you to help ensure compliance with FDA QSR (Title 21 Part 820) and ISO standards (9000:2015 & 13485:2016).
We are members of the American Society for Quality and have been helping clients since 1996. We have a proven and impeccable track record with our clients. This track record is demonstrated by the fact that no PCS client has ever been subjected to a US FDA 483, a Warning Letter, a Consent Decree, or even a Major Non-Conformance.
We build the systems which enable compliance to FDA regulations and to ISO standards ... the same systems which then ensure that you remain in compliance.
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Management Consulting, Quality Assurance | San Diego, CA