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.
Medical Device Manufacturing Business Needs
- 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.
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.
Redefine Medical Device Manufacturing
MasterControl has the tools you need to cultivate agile, customer-centric medical device manufacturing. Make measurable improvements to your production operations, performance, and products.
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One of our biggest pain points with the paper system was ensuring that people are appropriately trained and the processes on the floor were being followed correctly. With MasterControl, there’s a connection between production and the quality system that verifies and checks those parameters [and] processes, to make sure they’re being done correctly by the correct people.
"Quality Excellence
Manufacturing Excellence
Medical Device Manufacturing Headaches? We Have Solutions.
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50%
Decrease in Batch Record Review Time
Using Manufacturing Excellence, Dendreon, a pioneer in cellular therapeutics, cut review and release time by almost 50%, while maintaining a right-first-time metric of 99%.
Flexible Pricing and Plans for Your Medical Device Company
MasterControl solutions are designed to optimize medical device manufacturing and help you develop innovative, safe, and effective medical devices. You can scale as needed and be agile enough to respond to inevitable changes in your industry and market.
Cloud-based Solution
Our cloud-based solution with flexible plans ensures you get all the tools you need to get the job done.
Any Business Size
MasterControl can accommodate small startups, global organizations, and everything in between.
Grows with You
As you grow, you can seamlessly upgrade and meet increased demand.
What Does the Future of Medical Device Manufacturing Look Like?
Rising customer expectations are increasing the urgency for digitized medical device manufacturing.
