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.
Optimised Quality Event Management
Medical device quality management infractions that turn up in audits are costly. With an optimised 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 optimise production by capturing critical production data in real time, quickly identifying and resolving production issues, and connecting systems, processes, and people.
Maximised 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 jeopardise compliance or cause costly delays.
See How Your Digital Maturity Compares to Other Med Dev Companies
You know you can’t afford to delay your journey toward digital maturity, but where can you get actionable advice to help your medical device organisation thrive in the digital era? This original research report from MasterControl examines the impact of digitisation in the life sciences industry and offers tips on optimising medical device manufacturing and quality management processes.
Download Research Report
Know the 5 Signs You’ve Outgrown Your Quality Management System (QMS)
When medical device companies struggle to keep up with the demands of the modern industry, their quality management systems are often the main culprit. To be efficient in life sciences manufacturing, it’s critical to recognise when you’ve outgrown your current QMS. This guide examines the signs that indicate when it’s time to upgrade your QMS to a solution that promotes — rather than impedes — business efficiency.
Download the Industry Brief
Solutions for
Medical Device Manufacturing and
Quality Management
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.
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. By automating version control, audit trails, and sign-offs, MasterControl’s fully connected medical device quality management solution optimises the handling of multiple product lines and eliminates the discrepancies that could increase regulatory scrutiny.
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.
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, a crucial capability for medical device manufacturing operations.
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, making it easier for medical device companies to uphold product quality and maintain consumer trust while meeting regulatory requirements.
Resources for Medical Device Manufacturers
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GxP Lifeline Blog Posts
Keys to Managing Change Control Effectively in Medical Device Manufacturing
Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.
Read the Article
EU to U.S. Market: Understanding 3 Core Regulatory Contrasts
Both the EU and U.S. markets are highly regulated, but there are important differences in medical device compliance that must be considered before taking the plunge. Cannon Quality Group examines three core regulatory contrasts that can make the difference in the success of your market entry.
Read the Article
ISO 13485 Requirements: FAQ About the Top Medical Device Quality Management Standard
Compliance with ISO 13485 requirements is evidence that a medtech manufacturer’s quality management system (QMS) and devices measure up to the highest standard of quality recognized worldwide. Just because the standard is widely acknowledged, however, doesn’t mean it’s well understood. Find answers to the most frequently asked questions about the medical device industry’s definitive QMS standard.
Read the Article
FAQ: Clarifying Process Verification vs. Process Validation in Medtech
To validate or to verify, that is the question medical device developers often wonder about their manufacturing processes. Learn the distinct differences between the two activities, why they’re both essential for compliance, and the circumstances in which each is required.
Read the Article
Case Studies
How a Platform Approach to Technology Modernisation Is Transforming Manufacturing Performance and Quality
Discover how a new approach to medical device manufacturing management has empowered Carestream Health to deploy fewer, more modern technology tools across their global manufacturing environment. See how a single platform for production and quality management has resulted in improved visibility, efficiency, productivity, and risk mitigation.
How Digitising 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. No more lost or damaged documents, no more waiting for documentation to be completed, and no more searching through filing cabinets and boxes to find a record and scan it for an audit.
Read the case studyReady to Get Started?
Begin your journey to optimised medical device manufacturing and quality management.
