• (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

QMS Consulting Services for the Medical Device Industry

Paradigm Consulting Services offers QMS element and system development, QMS implementation, external and internal auditing, audit preparation (FDA, ISO, customer, and supplier), quality engineering assistance, and strategic QMS consulting services.

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.

Paradigm Consulting Services specializes in assisting clients in the medical device design and development, medical device manufacturing, or biotechnology sectors. Our client list includes …