Accredited Test Methods and Capabilities for Medical Devices

When Deciding on a contract manufacturer to satisfy your testing and measuring demands of medical devices, you will need to make certain they have the perfect qualifications, the ideal gear, and valid test procedures. In this blog article, I will describe what a licensed test process is and what is needed to guarantee accurate and dependable results. For test methods to be licensed, they should attain certain quality standards based on global standards. When a test procedure is licensed, the test method in addition to the lab, have been assessed and approved by an accreditation body. There are many Quality standards to achieve, not just in regards to validity and compliance of test procedures. Also, equipment and machines have to be valid. Staff need to possess the necessary education to take care of machines and equipment, in addition to carrying out the test procedures. Documentation has to be in order and massive amounts of test data will need to be backed up.

Medical Device

Basically, the whole technical competence of the lab has to be determined. To be able to make certain that the test methods maintain their high quality, the certification bodies run regular controls. The template for Our accredited tests is used for all tests, which ensures a top quality on each activity in our test lab. Our lab is highly efficient because of variety of variables such as suitable testing facilities and equipment, valid testing techniques and quality assurance processes, qualified and well trained operators, traceability of measurements to national standards and accurate recording and reporting processes. It follows that we can guarantee our clients that we provide them with accurate and dependable results. Many contract Manufacturers don’t have the capabilities to perform test methods in their own centers. Instead, they will need to send the goods to an external laboratory to run tests after every adjustment.

This process could take a long time. Having a medical device testing lab in relation to the development department means a lot of flexibility. Tests can be performed immediately and the practice of switching between alterations and testing takes just a couple of minutes. Additionally, it is possible to perform multiple tests in the exact same day. Having the ability to perform test methods in relation to the development department increases the general level of quality for different tests, the lab in general and the medical devices specifically. Consequently, this contributes to safer medical devices and greater patient safety. At Elo’s MedTech, we can conduct a range of tests in our test lab in Sweden. The lab is connected to our development department, which gives us the option to be very flexible to our clients. We can execute tests based on our client’s requirements and needs, and it may be done on short notice.