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