Medical Devices and Pharmaceuticals
Design control, traceability and validated processes built into the engineering tools, not added afterwards.
Innovation with a paper trail
Medical device and pharmaceutical companies must prove how every product was designed, verified and manufactured. NomuTech configures Designcenter NX for device design, Simcenter for performance and safety simulation, Teamcenter for design history files, change control and quality processes, and Tecnomatix for validated production lines. Regulators get the evidence; engineers keep the freedom to innovate.
Where we help
The engineering challenges we solve most often in this industry
Design control
Requirements, risks, designs and verification linked in Teamcenter as the basis of the design history file.
Device performance
Fluid, structural and thermal behaviour of devices simulated in Simcenter before clinical testing.
Validated production
Tecnomatix models cleanroom lines and process flows so validation starts from a digital twin.
Change control
Every change assessed for regulatory impact and approved through a controlled workflow.
Recommended Siemens software
Supplied on subscription, implemented and supported by NomuTech
Designcenter NXDevice and packaging design with human-factors and tolerance tools.See the product
Simcenter 3DStructural, fatigue and thermal simulation of implants, instruments and housings.See the product
TeamcenterDesign history file, quality management and change control for regulated products.See the product
TecnomatixProcess planning and simulation of pharmaceutical and device production lines.See the productFrequently asked questions
Does Teamcenter support ISO 13485 and FDA design control?
Yes. Teamcenter's quality and change processes are used by medical device companies worldwide, and NomuTech configures them to your quality system.
Can simulation replace some physical tests?
Often, yes. Simulation evidence is accepted for many verification activities when the models are validated, which reduces the number of physical tests.
Is the software validated for regulated use?
Siemens provides validation documentation packages for Teamcenter, and NomuTech supports your own computer system validation.
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