PhysicalDevice(Hardware)--IntendedUse(Medical)--butnotadrug Hardware instrument,apparatus,implement,machine,contrivance,andetc.,oranypart,accessory...Intended: fordiagnosisofdiseasefortreatmentofdiseasetoaffectstructure/functionofthebody FDAMandate:Assure...
Creating innovative, one-of-a-kind medical device components that advance the manufacturing boundaries of what is possible, especially for minimally invasive surgical processes and life-saving devices such as stents Spectrum’s dedicated additive manufacturing technical team has the depth of knowledge and...
This maximization of quality is an outcome that is especially important in manufacturing critical-use medical devices. For more information on scientific molding, including the processes and tools used for testing and monitoring, read The Importance of Scientific Molding in Medical Device Manufacturing. ...
Clinical GMP regulations ensure safe and high-quality investigational drugs for human use. Learn how Akadeum follows good manufacturing practices.
Pharmaceutical and medical device manufacturing often presents specific occupational risks, particularly when working with the advanced technology found in imaging equipment and other products. While ensuring the safety of your team is essential, it shouldn't come at the expense of productivity. ...
That is why we have developed a robust supply chain solution, offering dependable manufacturing, real-time inventory management and electronic purchasing. Trust Gore to deliver the right products at the right time, enabling you to focus on patient care. Discover how Gore can support you today. Be...
Biocompatibility testing is crucial in the development and manufacturing of medical devices to assess any potential risks and ensure their safety. It is a
U. Müller:The MDR contains only a few specific requirements for the manufacturing process as such. But if we look at the broader picture in relation to the requirements in the MDR, the advantages of continuous process monitoring are obvious: as well as simple, additional ...
Generative design is transforming many industries by enabling optimized, efficient, and innovative solutions. Inmanufacturing, it facilitates the design of complex and resource-efficient parts, while inarchitecture and construction, it promotes sustainable, space-optimized designs. The automotive and aerospace...
A manufacturing execution system (MES) is a software-based solution used in manufacturing to monitor and control production processes on the shop floor.