Direction of support ; Joint R&D : Technical support · Conduct joint research utilizing future leading core technology and consumer tailored joint technology infrastructure. Design prototyping : Prototype production support using facility and equipment · Medical device design and analysis · Support for molding production using 3D printer · Medical device ultra-precision processing and measurement · Precision machining of major parts for medical devices, Testing, inspection, and evaluat...
With a deep understanding of the product commercialization cycle, and a number of skilled technical specialists, our medical device design services team can help you bring your concept through appr...
Design Control Guidance For Medical Device Manufacturers · Guidance for Industry · March 1997
Medical devices are rapidly becoming smaller, more connected and more intelligent—enabling comfortable, user-friendly, wearable and implantable devices. Future medical device market...
Design and Development of Medical Devices in the perspective of ISO 13485:2016 and Medical Devices Industry
Spotlights ; The Medical Device & Design Group comprises Academic Staff, Research Staff, & Postgraduate Students. ; The Medical Device & Design Group's latest publications can be found here. ; The Medical Device & Design Group's latest news can be found here.
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Update: January 31, 2024 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulat...
Master design controls for medical devices and ensure compliance and safety with these expert solutions!
Medical devices of all kinds must be designed to withstand the structural and operational requirements associated with normal use, drop, and misuse, all while balancing weight and cost...