Medical Device manufacturers know that every single part must comply with all the engineering specifications and government regulations required as well as the strictest labeling requirements of any manufacturing sector contained in the 21 CFR part 800 series. There is zero tolerance for defects and the FDA demands absolute order and part traceability and end-to-end Production Control through the use of an electronic Device History Record or eDHR.
Quantum automates and provides control throughout the entire production process.
It eliminates errors, collects the data you need to remain compliant on every part and begins the eDHR at order initiation, so you know all production data is captured every time. Quantum Engineering ensures part compliance with approved Work Instructions and any Work Order changes with automated data collection and tolerance checks throughout production.
Doing prototyping or first articles?
For new part production in Medical Device, Quantum handles every revision of the engineering required to complete the production-ready part build book. Get traceability not just to the part you made but to the engineering behind the part. Know what you made, how and why you made it that way.
CIMx has 25 years' experience bringing lock-tight compliance control to U.S. Medical Device manufacturing. Bring the processes proven by the most successful shops in the world to your business today.
The ability to record, react and report at every phase of production is essential in the Medical Device manufacturing industry. Demand build conformance with every-stage quality gates, tolerance checks and sequential approvals to support ISO 9001, CAPA, 21 CFR part 800 series, 21 CFR part 11 and eDHR regulations.
Quantum automatically documents every asset, revision and operator involved in an order in a permanent historical record.
As the demands on Medical Device manufacturers increase annually, with stiff penalties on auditable record trails, operator certification and labelling restrictions, you need conformance of every production step of every Order you complete.
From sourcing to shipping, Quantum enforces conformance to every specification that is required. Deliver the agility and shop floor intelligence your customers demand with Quantum.
Quantum has been proven to:
Control and document every engineering iteration, every part used and every outcome with Quantum’s lock tight revision control prototyping.
Issue dispositions with a single click and deliver your customers the most comprehensive as-built production records in the market.
Experience the impact of Quantum in a 15-minute live demonstration. Share your stories with our Experts and learn how other manufacturers have already solved the same problems you face every day.
Experience how Quantum:
If you’re still not convinced Quantum is the right fit for your shop, our Experts can send you a list of alternative solutions from our extensive network.
"Quantum increased our production by 35% and cut our scrap by about 80% in less than six months."
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VP of Manufacturing Midwest Manufacturer
"Quantum gives our team a visual into every operation on our floor in real-time. I'm never out of the loop."
Production Manager Industrial Production
"We chose to partner with CIMx again because we know they can take our company to the next level."
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Operations Supervisor Aerospace Manufacturer