More and more medical devices are tailored to the specific anatomy of the patient. Which makes sense! Why settle for a size S, M, L or XL implant, when the implant can be tailor-made? These custom-made devices are exempt from CE marking, which seems to be a free-pass for some (companies and hospitals!) to cut corners and compromise on quality.
Custom-made devices (as a product) cannot (yet) be CE-marked, so make sure to certify the process instead of the product. Although the final product is always (slightly) different, the process to design and manufacture is always the same! Also, the MDR requires manufacturers (art. 10) and in-hospital 3D labs (art. 5.5) to implement a Quality Management System (QMS) and although it doesn’t specify what kind of QMS, a system according to ISO13485 makes the most sense. Certification of such a QMS is basically a process certification. A fully digital Quality Management System is the most powerful and accessible.
QasE3D can help you to deliver high quality 3D printed custom-made devices, following Annex XIII of the MDR and assist in the implementation of an easy-to-use, digital QMS.