• (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.

Your Quality Management System

is an essential – and an integral – aspect of your company if you’re engaged in the medical device design and development, medical device manufacturing, or biotechnology sector. Developing and implementing your QMS system elements to the FDA regulations and ISO standards, and then maintaining compliance, is a daunting endeavor for most. And, for start-ups, the cost associated with dedicated QA representatives can be prohibitive. With our QMS assistance, you can focus on your core business objectives … and on growing your company.

Our specialty is blending new or revised work effort and adjusting it to your specific situation and operational requirements. We also represent companies during FDA and state audits, and have taken numerous clients through the ISO (International Standards Organization) certification process. This includes everything from selection of a registrar through your final certification audit. Our reputation ... is impeccable.

Establish the groundwork for your company’s growth, enhance your quality system, and ensure on-going regulatory compliance with our comprehensive and cohesive expertise in QMS development and QMS support. Let Paradigm Consulting Services help you to prepare for – and to meet – your QMS compliance issues today, and your QMS obligations tomorrow.

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.


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