Balanced Quality Systems and Regulatory Compliance
About Us
Edwin L. Bills,Principal Consultant, Bilanx Consulting LLC
American Society for Quality:
Regulatory Affairs Professional Society:
Certified Quality Auditor
Regulatory Affairs Certified
Certified Quality Engineer
Certified Quality Manager
Member of standards committees·
AAMI/QM4·WG1 Quality Systems and also WG4 Risk Management
AAMI/EV WG5 Hospital Beds sub TAG·
Liaison TC 198 (sterilization) to SC62 A (IEC 60601-1)
Founding Member, FDA Hospital Bed Safety Workgroup
Experience:
Over 24 years experience in the field of quality systems, 6 years in electronic control systems and 18 years in United States, Canadian, and European Union regulatory requirements for medical devices. For questions or to request detailed CV e-mail ed.bills@bilanxconsulting.com or call us at 843-810-2157. You may also write us at our offices at 20 Chestnut St. Sumter, SC 29150.
Shirlee A. Bills, President, Bilanx Consulting LLC
Bilanx Consulting LLC is a Corporate Member of AAMI
