Presentation
MDD17 - ISO13485 Certification as a Human Factors Service Provider
DescriptionISO13485 is a quality management standard designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. Although the primary audience for the standard are device manufacturers, there is much value for Human Factors Service Providers to ensure their processes are in alignment with ISO13485.
Human Factors Providers may be critical suppliers for medical device manufacturers. A critical supplier is defined as a supplier delivering materials, components or services that may influence the safety and performance of the medical device. ISO13485 requires organizations to evaluate and qualify their critical suppliers, a necessary process that can be complicated and require considerable time and resources to carry out. Achieving ISO13485 certification as a Human Factors Provider can help simplify this process and provide value for both the Provider and their manufacturing clients by establishing processes that support the clients’ QMS from the get-go, hold the Human Factors Provider accountable for a high standard of quality, and simplify the critical supplier qualification process for clients by demonstrating compliance with ISO13485 through external third-party auditors.
Due to the unique position of Human Factors Providers in the medical device development process, pursuing ISO13485 certification poses unique opportunities and challenges. This presentation will cover the role of Human Factors Providers in ISO13485, Healthcare Human Factors’ ISO13485 certification journey, key differences between pursuing ISO13485 certification as a Human Factors Service Provider compared to certification as a device manufacturer, and key considerations related to designing a QMS as a Human Factors Provider.
Human Factors Providers may be critical suppliers for medical device manufacturers. A critical supplier is defined as a supplier delivering materials, components or services that may influence the safety and performance of the medical device. ISO13485 requires organizations to evaluate and qualify their critical suppliers, a necessary process that can be complicated and require considerable time and resources to carry out. Achieving ISO13485 certification as a Human Factors Provider can help simplify this process and provide value for both the Provider and their manufacturing clients by establishing processes that support the clients’ QMS from the get-go, hold the Human Factors Provider accountable for a high standard of quality, and simplify the critical supplier qualification process for clients by demonstrating compliance with ISO13485 through external third-party auditors.
Due to the unique position of Human Factors Providers in the medical device development process, pursuing ISO13485 certification poses unique opportunities and challenges. This presentation will cover the role of Human Factors Providers in ISO13485, Healthcare Human Factors’ ISO13485 certification journey, key differences between pursuing ISO13485 certification as a Human Factors Service Provider compared to certification as a device manufacturer, and key considerations related to designing a QMS as a Human Factors Provider.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives