Paradigm Consulting Services
Medical Devices - Vista, California, United States
Paradigm Consulting Services Employees
Paradigm Consulting Services Details
Paradigm Consulting Services is a comprehensive Quality Management System development and implementation consultancy. We specialize in the Medical Device and Biotechnology industries and have an impeccable reputation in those sectors. We provide external auditing, audit preparation (FDA, ISO, customer, and supplier), quality engineering assistance, and strategic QMS development and consulting services. We can provide assistance on specific elements of your QMS or develop and ensure implementation of your entire QMS program. In either case, our work-product is thorough and seamlessly integrated to your operational structure.Our specialty is making an accurate assessment of your existing resources and capabilities, and blending that reality with both new and revised work effort to align with 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, beginning with the selection of a proper registrar through to your final certification audit. We build the systems which enable compliance to FDA regulations and to ISO standards … the same systems which then ensure you remain in compliance.
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