• (619) 515-4556
  • paradigm@qualityconsulting.com

FDA and ISO consultants to Medical Device developers and manufacturers

FDA and ISO consultants to Medical Device developers and manufacturers

A Comprehensive – and Sensible – QMS Consultancy

A Demonstrated Reputation of Efficiency and Success … An Earned Reputation of Client Loyalty

Paradigm Consulting Services is a QMS management consulting firm comprised of senior-level management and engineering professionals. We have decades of experience "on the outside" as consultants and decades of experience "on the inside," as well, so we know what works … and, what doesn't. This unique blend of both experiences enables us to offer a broad array of QMS-related strategic consulting and systems development to you and your company. The reputation we have developed – and, that we take care to nurture – is flawless.

Whether you’re a Fortune 500™ company or a start-up, when you need help with FDA or ISO compliance, you can rely on strategic and focused management consulting provided by Paradigm Consulting Services. While we specialize in small to mid-size environments, we work with entities of all sizes, providing objective expertise in QMS development and helping you comply with federal regulations and international standards.

Paradigm Consulting Services is not a provider of “canned” services and products. Your particular resource-base and capabilities are critically important, and all of our work-product is tailored specifically to your company. Whether the undertaking involves a specific element, a particular selection of elements, or the entire system, we can either work with your existing procedures or develop new ones. In any event, our work-product will be specific to your company, for use in your facility and by your staff.

Our staff has a combined 100+ years of experience in Quality Assurance and Regulatory Affairs / Compliance, and is focused on your success. In business since 1996, Paradigm Consulting Services has an impeccable and proven track record of success. 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 for any work that we have done, or that we neglected to do.

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Members: American Society for Quality; Regulatory Affairs Professionals Society.