Over 350 medical device 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.

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.


MasterControl’s 510(k) submissions software helps ensure your device submissions are connected, efficient and compliant.

The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

Medical device reporting (MDR) is critical to compliance. Meeting the regulatory requirements for MDR, however, is always a challenge. And trying to do so with disparate systems only increases the difficulty. Electronic medical device reporting software makes compliance easier.

Managing an electronic trial master file (eTMF) is a complex and labor-intensive effort. Centralize and streamline your clinical activities with MasterControl eTMF software systems.

MasterControl's supplier management solution automates supplier management processes and ensures supplier quality and compliance.

A clear path to global regulatory submissions.

Simplify clinical management with a single platform. MasterControl allows you to connect all clinical data, documents, tasks and processes.

MasterControl offers the tools needed to digitize, document and manage all your product variations.

MasterControl software automates equipment calibration processes. It helps manufacturers improve their performance and ensure audit-readiness.

MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.

Unify all risk-related activities and documents for efficient and consistent risk management.

Streamlined investigation and resolution of product deviations. Improved quality. Simplified compliance. MasterControl deviation management software can help you make it happen.

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

Make sure gaps in employee training don’t derail your regulatory compliance.

Quality can never be a differentiator if it's an afterthought or a box to be checked. A complete, end-to-end digital quality management system makes quality at the source possible – and compliance issues a thing of the past.

Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.


MasterControl, Inc.

6350 South 3000 East

Salt Lake City, UT 84121


Phone: Sales 1.888.873.5164


  • This guide will help you understand the fundamental components of a Quality Management System (QMS) software and how QMS solutions are evolving to keep pace with business dynamics.

  • MasterControl is the foundation for connected quality data and complete product quality. It unifies applications, data, and documentation across your entire product development life cycle, from concept to commercialization. Go beyond proactive quality management and unleash the intelligence and insights concealed in unstructured data. Discover how the MasterControl Platform can make your vision of truly connected quality data a reality.

  • How adopting a data-driven and technology-supported approach to quality and product life cycle management can enable pharma and biotech organizations to not just survive, but thrive.

  • The digital documentation layer of quality and compliance processes is still critical and will never go away, but advanced technologies are helping life sciences organizations unlock the data side of the equation.

  • Explore the state of digital transformation in manufacturing and learn how you can extend your digital edge.

  • This ebook explores the current landscape of the medical device industry and the forces taking shape today that will drive growth into 2030 and beyond. From new technology to shifting patients’ experiences, we’ll explore how a wide range of issues are affecting product development and innovation, as well as the impact of digitization and data when it comes to device regulations and operations.