The Human Element

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.

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 and errors of manual data entry.

Secure Control 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 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. 

Quantum delivers: 

  • Engineering Change Management
  • Work in Progress (WIP) reporting
  • Complete Electronic Device History Records (eDHR)
  • Secure record keeping
  • Quality checks enforcement
  • CAPA Tracking and Management
  • End-to-End Production Control
  • Materials traceability
  • Conformance Approval Sequencing
  • 21 CFR part 800 sequencing reporting
  • 21 CFR part 11 capture
  • Operator certification
  • Work center compliance
  • Good Manufacturing Process (GMP) support
  • ISO 9001 certification
  • Integrated, real-time Scheduling
  • Tolerance management and validation
  • Data collection for every step in the process

Questions?

 

Medical Device Impact

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:

  • Increase production throughput,
  • Increase control with automatic records,
  • Eliminate recalls, returns and turn-backs,
  • Deliver ahead of schedule and under budget and
  • Keep 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