At the 3D Printing Festival held in Kyiv, Vladyslav Kasianenko, the director of Med Quality, presented a report on the topic “Conformity Assessment of Custom-Made Medical Devices Manufactured Using 3D Technology.” In his speech, Vladyslav shared valuable experience and knowledge regarding the certification of custom-made medical devices.
The presentation included key points such as:
– The increasing use of 3D printing in medicine and the importance of conformity assessment for medical devices according to Technical Regulation No. 753.
– Identifying risks associated with the manufacturing of custom-made medical devices, including the use of low-quality materials and improper manufacturing conditions.
– The process of preparing technical documentation, which includes preclinical and clinical trials, labeling, and product identification.
– The steps necessary for the successful registration of custom-made medical devices.
The presentation sparked great interest among festival participants, as it raised relevant issues of safety and quality of medical devices manufactured using 3D printing technology.
We invite everyone interested in this topic to download the presentation here and watch the recording of the speech!
On our website, you can find the 2024 Training Events Plan. We invite you to familiarize yourself with it and participate in upcoming events.
If you have any questions, we are happy to assist. Please contact us at 063 557 37 37 or email info@medquality.com.ua.
