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

E-mail: GSyring@QRASupport.com

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:     http://www.AAMI.org

Food and Drug Administration:        http://www.fda.gov

Health Canada: The Canadian Regulatory Body       http://www.hc-sc.gc.ca

Contact: Gary Syring, RAC

Quality & Regulatory Associates, LLC

800 Levanger Lane

Madison, WI 53589

Phone: 608 877-2635

E-mail: GSyring@QRASupport.com

Updated: August 2020