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
Fax: 608 873-7382
E-mail: QRASupport@AOL.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:

• Auditing Quality System Compliance
  
  
• CE Mark Compliance
  
  
• Create and Review Product Change "Letters to File"
  
  
• FDA Facility Registration and Device Listing
  
  
• FDA Good Manufacturing Practices (GMP), Quality System Regulation (QSR) Development and Compliance
  
  
• FDA Quality System Audit Inspection Support
  
  
• FDA Regulation Interpretation and Guidance
  
  
• International Regulatory Compliance
  
  
• In Vitro Diagnostic Device Directive Compliance and Support
  
  
• Medical Device Directive Compliance and Support
  
  
• Medical Device Reporting and Complaint System Compliance
  
  
• 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
  
  
• Submission Strategy and Implementation
  
  
• United States Agent for Foreign Manufacturer of Medical Devices
  
  
• Warning Letter Response

Contact: Gary Syring PE, RAC
Quality & Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589

Phone: 608 877-2635
Fax: 608 873-7382

E-mail: QRASupport@AOL.com

• Quality and Regulatory Links
  
• Overview: FDA Regulation of Medical Devices
  
• Export of Non-FDA Approved or Cleared to Market Medical Devices
  
• Transfer of 510(k) Ownership
  
• ISO 9001:2000, Notes for Medical Device Manufacturers