Medical Device Quality Manufacturing

Medical Device Manufacturing Errors Impact Patients

Your innovative medical device won’t help patients if production errors keep you from getting it to them.

Prevent Errors and Nonconformances From Halting Production

One data entry error or missed quality detail can keep your product off the market — catching up is nearly impossible.

The key to successful medical device quality manufacturing is a modern, manufacturing execution system (MES) with electronic device history record (eDHR) technology that eliminates errors.

  • eDHRs that improve your record processes and production metrics.
  • Better data for effective decision-making.
  • Assurance of successful audits and compliance.
  • On-time releases of high-quality medical devices.

How Much are Quality Events Costing You?

Medical device quality management infractions that show up in audits are costly. With an optimized quality management system (QMS), you can prevent costly issues such as:

  • Large amounts of waste and scrap.
  • A Form 483 or Warning Letter.
  • Fees for mitigation and compliance consultation.
  • Delays in getting to market.
Learn More About Our QMS

Right First Time, Every Time

When producing high-quality, in-demand medical devices, meeting current good manufacturing practice (CGMP) requirements is necessary and challenging.

Using MasterControl Manufacturing Excellence, medical device manufacturers can optimize production.

  • Capture critical production data in real time.
  • Quickly identify and resolve production issues.
  • Connect systems, processes, and people.
See Our Modern Manufacturing Solution
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