Functional Safety Testing

Traditional safety assessment focuses on potential hazards from electrical, mechanical or other aspects of a design occurring during usage, while functional safety focusses on the reliability of the product to function safely and correctly in response to its inputs.

As more and more software used in medical devices, the associated risk of physical injury or damage (hazard) to the health and well-being of patients and operators who using them is increasing. It is critically important to ensure the safety, security and reliability of software.

STEMart provides functional safety testing to help manufacturer build safety into your medical device development process.

Standards

• IEC 61508: General safety standard covering electrical / electronic / programmable electronic safety related systems
• IEC 62304: Medical device safety standard covering entire software life cycle processes
• ISO 14971: Risk management

Functional Safety Testing

• Identification of essential performance of medical device
• Evaluation of medical device compliance with IEC61508
• Classification of medical software

STEMart helps manufacturer assign a safety class to their software system based on its potential to cause a damage to the health of patient, operator or other people.

The software is classified into three levels:

• Class A: No injury or damage to health is possible;
• Class B: Nonserious injury is possible;
• Class C: Death or serious injury is possible.
• Evaluation of medical device software life cycle processes according to IEC 62304

STEMart provides a broad range of services to evaluate the reliability of the following software:

• Software which is itself a medical device;
• Software which is used as a component, part, or accessory of a medical device;
• Software which is used in the production of a medical device.
• Risk analysis assessment according to ISO 14971

SETMart provides a wide range of functional safety testing to help safeguard the safety of patients and operators, and increase market acceptance and positive brand associations of manufacturers. If you want to learn more detail about our functional safety testing service, or would like to consult with the experts at STEMart, please feel free to contact us.