For all you do:


Quality System Development and Compliance


Regulatory Affairs Strategies and Implementation


Quality & Regulatory Associates


is here to help you !



Quality & Regulatory Associates, LLC

Madison, WI



Contact: Gary Syring


Phone: 608 877-2635






Quality & Regulatory Associates provides practical and experienced quality system and regulatory affairs consulting support to Food and Drug Administration (FDA) and International regulated industry.



Areas of Quality and Regulatory Affairs support:


·         FDA Regulation Interpretation and Guidance


·         510(k) Pre-Market Notification and IDE Submission Strategy and Implementation


·         Create and Review Product Change "Letters to File", rationale for device changes without related FDA 510(k) Pre-Market Notification submission

·         FDA Facility Establishment Registration and Device Listing

·         FDA Good Manufacturing Practices (GMP), Quality System Regulation (QSR) Development and Compliance

·         Auditing Quality System Compliance

·         FDA Quality System Audit Inspection Support


·         Medical Device Regulation, CE Mark Compliance for Europe


·         International Regulatory Compliance


·         United States Agent for Foreign Manufacturer of Medical Devices


·         Pre-Clinical, Clinical Design and Implementation


·         Quality and Regulatory Affairs Management


·         Quality System Registrar Interface, Quality System Selection and Development


·         Recall Strategy Development and Implementation


·         Reply to FDA Inspection Observations Form 483


·         Safety Agency Interface


·         Standards Interpretation and Conformance



Quality and Regulatory Links:


Association for the Advancement of Medical Instrumentation:


Food and Drug Administration:


Health Canada: The Canadian Regulatory Body




Contact: Gary Syring, RAC

Quality & Regulatory Associates, LLC

800 Levanger Lane

Madison, WI 53589


Phone: 608 877-2635





Updated: August 2020