Medical device testing is a decisive step in transforming a unique design into a marketable and reliable product.
Our experiment puts the product through a complete medical devices business assessment and helps you demonstrate compliance with rules and regulations around the world. The medical device testing offers 11 different types to perform to evaluate the quality of the medical device.
11 different types to perform to evaluate the quality of the medical device
1. Verification
Verification testing related to offering the procedures that can determine every stage of the growing process is implementing the previous step. The objective is that the system will detect all the errors possible.
2. Validation
Validation is a form of medical device testing that can help you evaluate a system component during the end of the developing process in determining whether it satisfies the designated needs.
3. Black box
There is no need for excessive knowledge of the medical devices’ internal structure because the primary goal is to check that the end-user needs are met.
4. White box
In this testing type, you must have considerable knowledge of the medical device’s internal structure because you will do the testing from the developer’s view. Generally, white box testing is entirely the opposite of black-box testing.
Therefore, the tester is only involved in exploring the medical device’s internal structure and obtaining test data from the offered testing.
5. Hardware testing
Hardware testing is not a single test but involves different tests, thus depending on its use.
Hardware testing is associated with considering reliability parameters that you may perform twice during the development process. Immediately after going through the design phase, you have to evaluate the reliability and robustness. After production begins, assess the reliability and robustness of the manufacturing process starts.
6. Software testing
Software testing involves different levels of evaluation:
Module testing:
This testing will relate to evaluation and stress testing of the person modules for the software program. It consists of verifying the layout and implementation of the designation at the program’s tiniest component.
Integration testing:
Once you are done with testing all the modules successfully, integration testing occurs. In this testing, you can integrate various modules to ensure that they work together reliably or not. The software may merge with the hardware to ensure that both can work as a system.
7. Functional testing
The primary function of this testing is that all functional needs are allowed to be met. This testing involves exercising modes and events, allowing you a transition between operational states and various software.
It would be best if you implemented functional testing to confirm that:
- You need to execute proper mode changes and produce appropriate outputs if given the correct inputs.
- The software widely generates likely output when anticipated input is given.
During this kind of testing, you should practice a connection test tool to examine:
- The correct development of remote protocols
- The functionality of software placed in the tested product
8. Robustness testing
The goal of implementing this testing is to discover how the medical device software functions given variable information.
Robustness testing assists you to decide whether the software can:
- Rescue from unexpected information
- Lock the system.
- Continue to run unpredictably.
9. Stress Testing
How medical devices will react to a situation in which the rate of information surpasses the quality expected.
This kind of testing is useful for defining the edge of security enduring in the medical device. It consists of overnight and weekend runs that gain the optimal advantage of the designated test time.
As an element of stress testing:
Information structures and global barriers under overflow conditions to discover the software response.
You can carry out the remote communications to verify that the interface transfer rate.
10. Safety testing
You can do safety testing to verify that the medical device works safely and assess the safety design entirely. It uses hazard analysis about hazards. However, these tests do not approach alerts or alarms because they simply cover failure situations.
11. Regression testing
This testing type needs to be performed whenever hardware or software changes will affect medical device testing.
Generally, you can use regression testing for confirming that:
This change makes the desired effect; no other component that relies on the modified portion is unfavorably affected.
Conclusion
Medical device testing is a diverse term to consider. You will come to know the significant medical testing technique. All types of testing are unique and worth considering to meet all your needs. Here in this article, we have enlisted all the types of medical device testing. Read the article carefully to know the complete information.