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