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Medical
Device Quality Systems Certificate
Program Overview
This program was developed
to meet the critical industry-specific educational needs in
quality assurance and present the regulatory and quality standards
that are required for the medical device industry. The coverage
includes evaluating the quality system as it conforms to FDA
regulatory requirements, identifying the medical device-related
risk assessment and evaluation, integrating the medical device
manufacturing strategies, evaluating corrective action plans,
and implementing quality auditing tools and techniques.
Medical Device Quality Systems Certificate
Required Courses
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Regulatory
Environment for Medical Devices |
3 |
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Risk Management
and Assessment for Medical Devices |
3 |
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Medical Device
Design and Manufacturing |
3 |
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Quality Auditing
for Medical Devices |
3 |
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Change Control
and Documentation |
3 |
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| TOTAL
CERTIFICATE HOURS |
15 |
Course Descriptions
Regulatory
Environment for Medical Devices
This course provides
an understanding of the basics into the Food and Drug Administration
(FDA) regulation and compliance with an overview of how the
various activities and positions within a medical device company
are affected by regulations using the FDA as the primary focus.
Topics include the applicable laws and regulations enforced
by the FDA, an introduction to international standards, the
regulations controlling medical device design and development,
the medical device approval process, laboratory and clinical
studies, the introduction to the Quality System Regulations
(QSRs), and the FDA inspection process.
Risk Management and Assessment for Medical
Devices
This course provides the students with an in-depth understanding
of the principles and techniques of identifying, evaluating,
and controlling risks associated with the development and production
of medical devices. This course covers risk management planning,
risk analysis process, and risk management reporting. Topics
include the relationship between regulatory requirements and
risk management, tools for hazard identification, methods for
the mitigation of risks, and approaches for analyzing risk verses
benefit.
Medical Device Design and Manufacturing
This course provides an understanding of the processes and procedures
using the Food and Drug Administration (FDA) regulation and
compliance for the designing and manufacturing of medical devices.
Topics include the design process, design tools and management,
product and process development, documentation, verification
and validation, post market surveillance, and corrective and
preventative actions.
Quality Auditing for Medical Devices
This course presents the principles and techniques for assessing
the adequacy of a quality system for a medical device manufacturer.
Coverage includes evaluating the quality system as it conforms
to FDA regulatory requirements, standards, review of standard
audit terms, audit types, audit concepts, and methods for planning,
conducting, and reporting audits.
Change Control and Documentation
This course covers the change control activities and procedures
that apply to the design of systems, the components within those
systems, labeling and packaging, device manufacturing processes,
production equipment, and manufacturing materials. Additional
topics include all associated documentation such as the quality
system procedures, standard operating procedures, the quality
acceptance procedures and data forms, and product-specific documentation.
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