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


  • Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 family of standards is a proven approach for turning aspirations into actual quality objectives. Here, we review key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.

  • Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

  • Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Learn more about FDA guidelines on the horizon for COTS software and tips on how to approach validation until such guidelines are finalized.

  • We need to remedy the fact that the vast majority of life science manufacturers are still on paper. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.

  • MasterControl, a global provider of software solutions for life sciences and other regulated industries, today announced it has reached $100 million in annual recurring revenue (ARR), led by their signature software solutions, Quality Excellence and Manufacturing Excellence, as well as the recent launch of MasterControl Insights.

  • With the right tools, supplier and vendor audits can be an effective mechanism for gaining that visibility and improving product quality. Digital supplier quality management tools can dramatically enhance supplier audits and vendor qualification audits in a number of ways.

  • When data is digitized and connected to other data points across the enterprise by the IoT, and analyzed by AI algorithms, the data becomes more visible, usable, and valuable. Several technologies have emerged to help life sciences companies excel in an increasingly digital economy. Here is what five of these technologies mean for the life sciences supply chain.

  • The supplier scorecard is an effective form of communication because it sets up a structured measurement of collaboration where the supplier always knows their score and how they’re trending. In this blog we outline five things to consider when creating a supplied scorecard.

  • In light of the disruption and the urgency around fast delivery of high-quality products, it makes sense that manufacturers and their suppliers might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners. Working with your supply partners to achieve their obligations starts with understanding your company’s existing supply agreements.

  • Read about most commonly cited conditions that led to the issuance of Form 483s to drug companies last year (as summarized by the FDA in the most recent 12-month inspection period on record) and practical tips for avoiding them.

  • The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

  • Medical device companies of all sizes are often concerned about speed-to-market, new device clearance overhead costs to maintain compliance, and lack of certainty about what is needed to maintain compliance, and fear of non-compliance consequences. We explain how to meet these compliance standards by following these best practices to bring new medical devices to market with success.

  • Security now needs a seat at the medical device design table, accompanied by its own list of requirements. Here are resources to identify specific areas to focus cybersecurity efforts throughout the product’s life cycle.

  • For fiscal year 2020, the most common FDA inspectional observations for biologics, devices, and drugs involved SOPs. To avoid a warning letter from the FDA, life sciences companies need a methodical approach to their SOPs.

  • In medical device development, speed, efficiency, and accuracy with document control processes are a top priority.  Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.

  • How can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? By designing for compliance you can meet this goal.

  • Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate.  A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.

  • Over the past year and a half, the global business disruption has created a sense of urgency around accelerating efforts to digitize and connect offline or siloed areas of operations. Most manufacturers see the benefits of digital transformation, but many don’t see the roadmap. Here are a few ways to apply digitization to enable agility and improve operations.

  • Medical device and pharmaceutical manufacturers are ultimately responsible for the products they make and sell, even if they outsource some or all of their manufacturing or other operations. To ensure that products are safe and meet the claims made for them, the FDA and other regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers. Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.

  • A provider of digital X-ray products and X-ray films with more than 4,400 employees in globally distributed locations was focused on updating their legacy systems. Read how a flexible solution has allowed them to deploy fewer, more modern technology tools across their global manufacturing environment with a single platform for production and quality management, which has resulted in improved visibility, efficiency, productivity and risk mitigation.