By using a design tool that can easily modify scanned-in data, designs are completed more quickly and accurately. On-demand webinar Next-generation design for medical devices Get products to market faster and overcome the barriers to innovation with next-generation solutions for medical device ...
Transforming medical device design with NX software 閱讀時間:24 minutes Today’s medical device companies and suppliers must address increasing product complexity in the electronics and mechanical realm. The challenge? Medical devices are becoming so complex and personalized that product designers have no...
Medical Device Cloud Platform CypherMed Cloud was built for medical devices from the ground up to support the unique requirements and capabilities that robust medical device cloud management demands. HIPAA, GDPR, CCPA compliant solutions ready to integrate with your advanced Medical Device. ...
Cardiovascular devices Scale new therapies faster and more effectively with AI-driven 3D insights for anatomical measurements and planning. Frequently asked questions What are the system requirements for Materialise 3-matic Medical? What is the relevant regulatory information?
Rising medical device recalls and costs push manufacturers to prioritize quality, reliability, and product design in manufacturing
development for Medical Devices and Digital Health Our clients are backed by some of the top research institutions We build custom mobile and web applications to improve people’s lives. Our focus Going hand in hand with our mission to work on projects that improve people’s lives we partner ...
Bluetooth for Medical Devices More Thought Leadership Certifications & Compliance Compliance to Global Standards Orthogonal’s Quality Management System is certified by BSI to ISO 13485:2016. Our Agile processes are compliant with IEC 62304, AAMI TIR:45, and ISO 14971, as well as FDA QSR, EU MDR...
医疗器械产品开发和制造的复杂性持续增加,而商业压力也在导致利润下滑。更糟的是,监管环境的变化会压制创新,影响上市速度。“智能”的设计控制方法可帮助 OEM 和供应商大幅提升生产力、速度和质量标准,同时应对复杂性和法规合规性挑战。 释放潜力以打造更好的医疗器械设计,以及 ...
Blog about software medical devices and their regulatory compliance. Main subjects are software validation, IEC 62304, ISO 13485, ISO 14971, CE mark 93/42 directive and 21 CFR part - page 1
A digital ecosystem for medical devices To help shorten time to market, leading medical device manufacturers have successfully adopted software-centric development approaches. The image shows key topics that influence and improve medical software design. Instead of keeping those initiatives separated, a ho...