1 Medical Electronics Flashcards
What is a medical device?
A medical device is a device intended for medical use and is used to treat and/or diagnose patients.
Give 3 examples of medical devices with description and intended use
Hearing aid: Hearing aids use a microphone, speaker and amplifier to amplify noise from the environment into the user’s ear canal.
EndoFLIP: Used during endoscopies to measure the diameter of the esophagus. It uses conductive bands to measure the resistance inside a saline filled balloon that can be inflated by the operator.
Pacemaker: Implanted in the patient’s chest. Electrodes supply electrical impulses to the heart to regulate the patient’s heartbeat.
What determines how much testing a device must go through?
The associated risk of the device.
State the 5 steps to release a medical device to market:
- Concept development
- Design freeze
- Design verification and validation
- Manufacturing readiness
- Market launch
What are the steps involves in concept development
- Define a clinical need
- Identify goals
- Identify and evaluate concepts
- Recommend for further development
What are the steps involves in design freeze
- Finalise specifications
- Converge to one concept
- Finalise design
- Show evidence of achieving requirements
What are the steps involves in design verification and validation
- Complete functionality testing
What are the steps involves in manufacturing readiness
- Complete full process validation testing
What are the steps involves in market launch
- Complete all design control requirements
- Gain regulatory approval
- Build product for launch
