Medical Device Manufacturing & Quality Management Solutions
Accelerate Compliance & Quality for Medical Devices
Ensure faster approvals, reduce errors, and streamline compliance.
See How Cochlear Transformed Compliance
MasterControl Offers 4 Key Advantages for Medical Device Manufacturers
Error Prevention
One data entry error or missed quality detail can keep your product off the market, and catching up is nearly impossible. The key to successful medical device manufacturing management is a modern manufacturing execution system (MES) with unparalleled electronic device history record (eDHR) technology that eliminates errors and prevents nonconformances and other quality issues from halting production.
Optimized Quality Event Management
Medical device quality management infractions that turn up in audits are costly. With an optimized quality management system (QMS), you can prevent costly issues like waste/scrap, Form 483s/Warning Letters, fees, and delays in getting to market. MasterControl’s Advanced Quality Event Management solution puts the power to design processes, build forms, and capture data entirely in your hands.
Right First Time, Every Time
When producing high-quality, in-demand medical devices, meeting good manufacturing practice (GMP) requirements is necessary yet challenging. Medical device manufacturers who rely on MasterControl Manufacturing Excellence optimize production by capturing critical production data in real time, quickly identifying and resolving production issues, and connecting systems, processes, and people.
Maximized Data Integrity
Missed signatures, incorrect calculations, and illegible entries are inevitable when medical device quality management and production records are maintained manually. With MasterControl solutions, you can avoid the issues that create rework, extend cycle times, and negatively impact product delivery and quality. Plus, you can prevent discrepancies that may jeopardize compliance or cause costly delays.
Solutions for Medical Device Manufacturing and Quality Management
Development Excellence
Ensuring proper documentation and quality management should be the goal for all medical device manufacturers from day one. Medical device companies can start product development on compliant footing with MasterControl Development Excellence, part of the fully integrated MasterControl platform.
Quality Excellence
Product quality is the top priority in medical device manufacturing. MasterControl Quality Excellence provides automated document control, change control, training management, audit management, corrective action/preventive action (CAPA) management, and unparalleled process connectivity for medical device manufacturers.
Supplier Excellence
Everyone involved in production — device manufacturers and their suppliers — bears the responsibility for ensuring quality consistency. MasterControl Supplier Excellence helps medical device companies ensure quality alignment throughout their supplier ecosystems by combining supplier quality management (SQM), approved vendor lists (AVLs), and supplier corrective action requests (SCARs) within the same platform.
Manufacturing Excellence
Medical device manufacturers often struggle to connect quality processes and manufacturing, and too many production lines are still reliant on paper. MasterControl Manufacturing Excellence eliminates paper dependency and automates the last mile of the manufacturing production process.
Postmarket Excellence
Once a medical device is on the market, its performance must continually be monitored. MasterControl Postmarket Excellence helps manufacturers track customer complaints and resolve issues efficiently.
- The Ultimate Guide to Digitizing Medtech Manufacturing
Based on industry research and customer use cases, “The Ultimate Guide to Digitizing Medtech Manufacturing” is a comprehensive guide that explores how a fully connected manufacturing solution can extend digitization to the “last mile” of production.
- The Ultimate Guide to Medical Device Quality Management
Medical devices are becoming increasingly sophisticated, as is the technology used in them and to create them. Quality professionals need to connect their data and use analytics to keep up.
- FDA and ISO Compliance for Medical Device Manufacturers
To provide medtech professionals with the regulatory information needed to manufacture compliant, high-quality, safe, and effective medical devices, this e-book summarizes the key FDA regulations and ISO standards applicable to device companies.
- 21 CFR Part 820 – ISO 13485 Harmonization
This Q&A document examines how the FDA’s harmonization of 21 CFR Part 820 and the ISO 13485 standard will impact clinical practices.
Case Studies
How Digitizing Operations Keeps Northeast Scientific a Leader in the Medical Device Industry
See how a leading medical device remanufacturing company is eliminating paper and getting products to market faster.