Need to trial your medical device?
Need a clinical professional to evaluate your technology?
FBE can help
SA Biomedical Engineering (SA BME) is the state-wide biomedical device management service for SA Health. All medical devices entering SA public health services must pass through SA BME doors before use.
SA Health is the government body responsible for the delivery of public health services across South Australia.
SA Biomedical Engineering departments are located within the major hospitals and have a close working relationship with SA Health's clinical professionals. They are seen as the source of medical technology expertise and assist with trialling, modifying and developing new medical devices.
SA Biomedical Engineering expertise
Benefits of working with FBE for your trial
- Over 40 years of experience in biomedical engineering, with expertise and skills in medical device research, design, procurement, management and maintenance
- Experience in design, facilitation and running of medical device clinical and animal trials
- The responsibility to ensure medical devices in SA Health meet Australia medical devices standards and regulations
- A close working relationship with FBE, making expertise available for clinical trials with a wide range of medical devices
- Trial medical devices within SA Health facilities
- 80 public metro and country hospitals with a large range of public health services
- 4900 public beds
- Access to experience in clinical trial design, ethics applications
- One ethics application for all public hospitals within Australia
- Ethics approval within as little as 2 months *
- Access to a wide range of clinical expertise within SA Health
- Clinical evaluation - focus groups
- Linkage to appropriate clinical expertise
- Access to wide range of patient types for trials
- Access to animal facilities
- Access to biomedical expertise
- Technical validation of medical device design
- Advice on Australian Standards and Regulations
Depending on the clinical trial, but typical for low & negligible risk applications.