The Human Element

There is zero tolerance for defects in Medical manufacturing. FDA approval demands absolute order traceability and end-to-end production control. Only Quantum eliminates errors and collects the data you need to remain compliant on every part, every time.

Quantum eliminate errors and automatically collects the eDHR data you need to remain compliant on every part, every time.

EXPLORE

Automatic eDHRs 

Both the FDA and your customer’s IRB insist on thorough and reliable production data. Only Quantum’s automatic eDHR eliminates the compliance risk of manual data entry.

Secure Approval Paths

Identifying issues before delivery is not enough to support your 21 CFR certification. Control rework with standardized, approved processes and eliminate mistakes once and for all.

Material Traceability

The materials required for your work are both time and environmentally sensitive. Track the life of every asset that goes into production with comprehensive serialized, part and lot records.
CIMx Manufacturing Medical

Track and Control Every Order

The ability to record, react and report at every phase of production is essential in the medical manufacturing industry. Demand build conformance with every-stage quality gates, tolerance checks and sequential approvals to support ISO 9001, CAPA, 21 CFR part 11 and eDHR regulations.

Quantum automatically documents every asset, revision and operator involved in an order in a permanent as-built record. 

Quantum Supports: eDHR, CAPA, 21 CFR part 11, GMP, ISO 9001, and more...

  • Complete Electronic Device History Records
  • CAPA Tracking and Management
  • End-to-End Production Control
  • Conformance Approval Sequencing

Questions?

 

Medical Device Impact

Medical Device manufacturers are faced with ever escalating demands for increased Quality, control and reporting. Quantum enforces build conformance to execute every order to spec. Deliver the engineering agility and shop floor intelligence your customers demand, with Quantum.

Quantum Delivers:

  • Increase production throughput
  • Eliminate recalls, returns and turnbacks
  • Deliver ahead of schedule and under budget
  • Serial, Part and Lot Traceability Records

 

Medical Device Production

INDUSTRY SPOTLIGHT

Quantum Prototyping

How competitive are your prototyping processes?

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.

Let's Get to Work

Schedule your live Quantum Impact demo today!

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:

  • Permanently Eliminate Errors
  • Improves Every Phase of Production
  • Sets the Stage for Your Future

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."
Read the full story
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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."
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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