Medical devices are extremely important in healthcare. They are used to provide doctors with images of internal organs and tissues that may be affected by disease. Quality control is a fundamental component of medical device manufacturing because the devices are incredibly sensitive and must work within a very tiny margin of error in order to produce accurate results. In this blog post we will summarise how medical devices are made, the advantage of using Non-Destructive Testing (NDT) in medical device manufacturing, common NDT techniques used in medical device manufacturing, regulatory compliance in medical device manufacturing and training and expertise in the NDT sector.
Understanding Medical Device Manufacturing
As mentioned above, medical devices are crucial equipment in the health sector. By nature, medical devices are incredibly complex and made from a huge list of components. Components vary in size and composition and fulfill a diverse range of functions. Quality assurance and safety control are very important in medical device manufacturing because they ensure components are non-defective, thereby facilitating correct operation of the devices they comprise and enabling accurate diagnoses for doctors.
The NDT Advantage in Medical Device Manufacturing
Non-destructive testing works by evaluating the structural integrity and compositional integrity of components used in medical devices. NDT works using light or sound waves or ultrafine particles to evaluate a test object without damaging it. The nature of NDT makes it affordable and efficient because a single component can be inspected to make sure the mould it sprung from is producing non-defective parts.
Common NDT Techniques Used in Medical Device Manufacturing
The most-common NDT techniques used in medical device manufacturing include radiographic testing and liquid penetrant testing. Radiographic testing is used to inspect small components that cannot be analysed by the naked eye. X-rays and gamma rays are used in conjunction with a display screen to check a part for flaws and discontinuities. Liquid penetrant testing coats test objects in liquid composed of extremely fine particles. When a light is applied to the test object following coating, any defects or flaws in its composition become visible.
In Australia, the Therapeutic Goods Association (TGA) governs the manufacture of medical devices. The regulation stipulated by the TGA ensures medical devices are safe, of high quality and effective. NDT ensures devices are safe by guaranteeing their components are structurally integrous and of high quality by certifying parts are not defective. The efficacy of medical devices is assured too by using NDT to inspect components before assembly.
Training and Expertise
NDT is a highly technical sector of the engineering industry and use of NDT equipment should always be performed by certified and trained professionals. NDT Australia supplies NDT equipment to engineers who may use the technology in their role overseeing the manufacture of medical devices.
Buy Non-Destructive Testing Equipment
NDT Australia can supply advanced non-destructive testing equipment no matter where you are in Australia. Contact us via our contact form or on (02) 9524 0558 to make an enquiry about any of the NDT equipment we have listed on our website. We are available from 7:30am to 4:00pm Monday to Friday.