Med Device

Medical Device Industry

Over 350 medical companies rely on MasterControl for connecting quality document and data processes that drive efficiency and actionable insights to help you accelerate breakthrough medical innovations. The MasterControl product lifecycle excellence platform is designed to provide medical device companies a single source of truth for product quality data across the entire enterprise and the wider ecosystem. It helps ensure that all teams working in regulatory, quality, supplier, manufacturing and postmarket functions can access the information they need to do their jobs more efficiently and effectively.

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Free Medical Device Resources

Explore useful resources designed to help medical device companies streamline processes, connect data and optimize performance. Select the resources you'd like to download below.

Medical Devices in hospital

Unlocking the Next Decade of Medical Device Growth

The medical device industry is constantly evolving. An aging world population, emerging markets, increased regulation, digitization and other trends are radically transforming the industry. Device companies that are poised to take advantage of these developments will become market leaders, while companies limited by antiquated operational or technology processes will find it difficult to adapt.

Person using manufacturing software on a laptop

Living in the New Data-Driven World of Global Regulations

Regulatory oversight of the medical device industry is at an all-time high, particularly in the areas of design, data and supplier control. To stay on top of these demands, medical device companies all over the world are turning to MasterControl to automate and streamline processes, enhance product development lifecycles, improve efficiencies and ensure compliance.

MasterControl Offers Three Key Advantages


Mobile Access

Users can access documents and perform tasks from anywhere with a connected laptop, tablet or smartphone. Mobile connectivity and access give users greater flexibility and helps boost overall efficiency and productivity.


Cloud Solutions

Cloud technology is a necessity for medical device companies. Without its speed and versatility, they will struggle to maintain a competitive edge. MasterControl's cloud-based solutions include dedicated teams and specialized tools to make your cloud transition simple and seamless.


Flexible & Effective Framework

MasterControl’s integrated quality management system (QMS) automates all documents- and forms-based processes, connects quality activities, and stores all documents and data in a central location.

Solutions for The Medical Device Industry

MasterControl Development Excellence™ Solution

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The MasterControl Development Excellence solution digitizes and automates the management of design history files (DHF) and device master records (DMR) to help embed quality directly into early product development. It facilitates cross functional collaboration and document control to ensure that documents are easy to track, retrieve, revise, approve, and share departmentally to improve efficiency, accelerate time to market and ensure compliance.

MasterControl Clinical Excellence™ Solution

Clinical Excellence

The MasterControl Clinical Excellence solution digitizes all the documents, collaborations, sites, study information and tasks throughout the clinical lifecycle for multiple sites and CROs. MasterControl effectively manages all interactions to ensure site protocols and audit readiness.

MasterControl Regulatory Excellence™ Solution

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The MasterControl Regulatory Excellence solution simplifies the management of documentation for submissions and dossiers, streamlines global registrations and harmonizes regulatory information with quality data. It simplifies and automates critical workflows associated with managing 510(k) registrations, technical documents and dossiers for global registration in multiple countries with a global checklist template designed to mirror regulatory pathways.

MasterControl Quality Excellence™ Solution

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The MasterControl Quality Excellence solution accelerates enterprise quality management and removes the anxiety associated with regulatory inspections and audits to proactively improve quality, accelerate time-to-market and create a sustainable competitive advantage. MasterControl streamlines and automates GxP processes and facilitates effective document control, change control, training management, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes throughout the product lifecycle.

MasterControl Supplier Excellence™ Solution

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The MasterControl Supplier Excellence solution increases visibility while ensuring quality and compliance across the supplier ecosystem - from sourcing through production and post market. MasterControl streamlines supplier management to ensure quality and compliance requirements are consistently fulfilled throughout the supply chain along the product lifecycle. It integrates supplier quality management (SQM) and approved vendor lists (AVL) management while automating document control and change control processes like supplier corrective action requests (SCARs) and supplier approval status.

MasterControl Manufacturing Excellence™ Solution

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The MasterControl Manufacturing Excellence solution helps bridge the paper gap between quality management systems and manufacturing execution systems by automating the labor-intensive last mile of the manufacturing production process. It helps eliminate paper-based DHRs and manual review cycles by automating the building, execution and review of DHRs and product family variations that increase productivity, cycle times and release delays to drive immediate improvement and operational efficiency.

MasterControl Postmarket Excellence™ Solution

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The MasterControl Postmarket Excellence solution allows device companies to effectively manage in-market complaints and close the quality management loop by automating actionable and intelligent postmarket surveillance as a catalyst for product improvement.

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