Your medical device is designed to help patients improve their quality of life—from treating minor illnesses to saving lives. The sooner you get your device on the market, the better for everybody.
But to do so, you must comply with regulatory requirements to ensure its safety through efficient medical device testing. Without adequate testing, you run the risk of faulty software that fails to get market approval or even a recall should an issue arise after its release. You can also choose a medical device service for your medical device testing.
When this happens, you lose time and money—and your reputation could be at risk. Testing serves as a formal process that ensures you and your medical device testing company are on the same page with regard to specific expectations.
Incorporating a set of test conditions and detailed steps that need to be taken, along with the appropriate test method validation, medical device testing offers a measurable mechanism to verify that you’ve accomplished your design goal.
Medical device testing for the FDA is defined by the level of concern. The type of harm that a device could pose to a patient will determine how rigorous the medical device testing will be. The verification process aims to identify as many failures as possible, as soon as possible, to ensure the device won’t fail in the field.
For a sound testing process, your first priority is to develop a robust software requirements document that:
- Clearly lays out every requirement
- Uses specific engineering language
- Serves as a living document, updated throughout the risk management process
All design decisions made are included in the design history file (DHF), which is used during the FDA approval process.