Management of Medical

Devices
Selected Topics in Biomedical Engineering (BM5922)
Biomedical Engineering , SAMS, GJU
2nd 2022-2023
Introduction to Medical Devices Management

Challenges
Importance of
Definition of associated with
medical devices
medical devices medical devices
management
management
Definition of Medical Devices

• Instruments, apparatus, machines, or other similar articles used for

the diagnosis, treatment, or prevention of disease or other medical
conditions
 an instrument, apparatus, implement,
machine, contrivance, implant, in vitro
reagent, or other similar or related article,
Medical including a component part, or accessory
which is: 

device • recognized in the official National Formulary, or the United

States Pharmacopoeia, or any supplement to them
• intended for use in the diagnosis of disease or other

definition conditions, or in the cure, mitigation, treatment, or

prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the

by FDA body of man or other animals, and which does not

achieve its primary intended purposes through chemical
action within or on the body of man or other animals and
which is not dependent upon being metabolized for the
achievement of any of its primary intended purposes.
 Ensures availability, safety, and
effectiveness of medical
devices

Importance
of Medical Improves patient outcomes
Devices
Management
Increases efficiency and cost
savings
 Complexity of medical devices

Challenges
Associated
Compliance with safety and
with Medical quality standards
Devices
Management
Rapid pace of technological
advancement
 Effective medical devices
management is critical for
healthcare delivery.

This course will cover various topics

Conclusion related to medical devices
management.

The goal is to equip you with the

knowledge and skills needed to
effectively manage medical devices.