Accredited Test Methods And Capabilities For Medical Devices

When choosing a contract manufacturer to fulfil your testing and measuring needs of medical devices, you need to be sure that they have the right qualifications, the right equipment, and valid test methods. In this blog article, I will describe what an accredited test method is and what is required to assure accurate and reliable results.

Quality assurance for test methods based on international standards

For test methods to be accredited, they need to achieve certain quality criteria based on international standards. When a test method is accredited, the test method as well as the laboratory, have been evaluated and approved by an accreditation body.

There are many quality criteria to achieve, not only when it comes to validity and compliance of test methods. Also, machines and equipment need to be valid. Staff need to have the required education to handle machines and equipment, as well as carrying out the test methods. Documentation needs to be in order and large amounts of test data need to be backed up. Basically, the entire technical competence of the laboratory needs to be determined. In order to ensure that the test methods maintain their high quality, the accreditation bodies conduct regular controls.

The benefits of having a test laboratory next to the development department

The template for our accredited tests is used for all tests, which guarantees a high quality on every activity in our test laboratory. Our laboratory is highly efficient due to a number of factors including suitable testing facilities and equipment, valid testing methods and quality assurance procedures, qualified and well trained operators, traceability of measurements to national standards and accurate recording and reporting procedures. This means that we can assure our customers that we supply them with accurate and reliable results.

Many contract manufacturers do not have the capabilities to carry out test methods in their own facilities. Instead, they need to send the products to an external laboratory to conduct tests after each adjustment. This process could take several months. Having a test laboratory in connection to the development department means a great deal of flexibility. Tests can be carried out right away and the process of switching between adjustments and testing takes only a few minutes. It is also possible to carry out multiple tests in the very same day. Being able to carry out test methods in connection to the development department also increases the overall level of quality for other tests, the laboratory in general and the medical devices in particular. Consequently, this leads to safer medical devices and higher patient safety.

Elos Medtech conducts accredited test methods for accurate and reliable results

At Elos Medtech, we can carry out a number of tests in our own test laboratory in Sweden. The laboratory is connected to our development department, which gives us the possibility to be very flexible to our customers. We can carry out tests based on our customer’s demands and needs, and it can be done on short notice. Our tests can be carried out at any step of the manufacturing process, from development and prototyping to assembly and packaging. As the development and testing of medical devices take place under the same roof, we save both time and money for our customers.

Elos Medtech conducts a number of tests for medical devices in own test laboratory

The products we test may include orthopaedic components, titanium screws, dental implants or instruments. We conduct various tensile, pressure and load tests on a number of different materials, such as plastics, metal, paper, and textiles. The tests are both static and dynamic, mainly focusing on strength, elasticity, and durability.

  • Drilling test
  • Tensile test
  • Pressure test
  • Strength test
  • Elasticity test
  • Durability test
  • Fatigue test
  • Torque test
  • Drilling and temperature test

I hope you found this article interesting! Please visit our website for more information or contact knowledge blog for more relevant blog articles.

4 Comments

  1. Rocel

    Hi Henrik,
    What you were saying in your article is interesting and it is advisable to a company to hire staff that need to have the required education to handle machines and equipment, as well as carrying out the test methods. Thank you for posting!

  2. Henrik Skoglund

    Lianying,

    You are absolutely right! The photo is from our production site in Tianjin. From our test lab in Sweden, we carry out a number of tests including the once mentioned in the article. Thank you so much for taking the time to comment on my post.

  3. Henrik Skoglund

    Hi Rocel,

    Thank you so much for your comment. I agree with you, educated staff is very important when it comes to carrying out this type of measurements – and also key to ensuring quality!

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