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Expert Profile
Edwin L Bills
Principal Consultant , Bilanx Consulting LLC
He has over 20 years experience in the field of quality and regulatory affairs.Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the committee.Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance.
Trainings by Expert
Overview of the Medical Device Risk Management Standard-ISO 14971
Category:
Medical Devices
,
Risk Management
,
All FDA Regulated Industry
,
GXP Medical Devices
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
Integrating Risk Management into the CAPA System
Category:
Medical Devices
,
Risk Management
,
All FDA Regulated Industry
,
GXP Medical Devices
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life Sciences
Risk Management Activities during Design Input
Category:
Medical Devices
,
GXP Medical Devices
,
R & D
,
Research & Development
,
Device R & D
,
Life Sciences
The Use and Mis-use of FMEA in Medical Device Risk Management
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
R & D
,
Life sciences QA/QC
,
Research & Development
,
Device R & D
Overall Residual Risk and Risk Acceptability for Medical Devices
Category:
Medical Devices
,
Risk Management
,
GXP Medical Devices
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life Sciences
Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
Category:
Medical Devices
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life Sciences
,
Documentation and Data Management
Safety Risk Management for the Pharmaceutical Industry
Category:
Drugs and Chemicals (Pharma)
,
Quality and Safety
,
Life Sciences
Medical Device Software Risk Analysis
Category:
Medical Devices
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers - Quality System Regulation
Category:
Medical Devices
,
All FDA Regulated Industry
,
Life Sciences
The Essentials of Food and Drug Administration Medical Device Regulations:A Primer for Manufacturers and Suppliers - Registration, Medical Device Reporting, Corrections and Removals (Recalls)
Category:
Medical Devices
,
All FDA Regulated Industry
,
FDA 21 CFR Part 11
,
Life Sciences