Medical 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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Medical Devices in hospital

Medical Device Regulatory Quality and Compliance

During the medical device development process, companies will stumble upon problems such as regulatory issues, limited resources, and timely delivery of finished products. Regulatory requirements such as 21 CFR Part 820, otherwise known as the Quality System Regulation (QSR), and ISO 13485, outline elements which, while intended to ensure product quality and safety, may often be viewed as contributing factors to such stumbling blocks. The MasterControl Product Lifecycle Excellence solutions help medical device companies leverage compliance requirements as an advantage by automating and accelerating quality and compliance processes throughout the entire product lifecycle - from product concept to commercialization - all on the MasterControl Platform™.


Operating in Global Regulations

Global regulatory oversight of the medical device industry is at an all-time high; particularly in the areas of design, data and supplier control. Consumers, as well as industry stakeholders, are demanding better, safer products, and regulators are being compelled to act on their demands. To stay on top of these intense business and regulatory demands, medical device companies of all sizes throughout the world are turning to MasterControl to automate and streamline processes and enhance product development lifecycles to improve efficiencies and ensure compliance.

Over 350 Medical Device Companies Around the World Rely on MasterControl

MasterControl Offers Three Key Advantages


Mobile Access

MasterControl allows users to access information and perform tasks using a tablet or a smartphone. Mobile access offers greater flexibility for users and helps boost overall efficiency and productivity.


Cloud Solutions

Cloud technologies are a necessity for medical device companies. Those without access to its speed and adaptability will struggle to maintain a competitive edge. MasterControl isn't just a cloud-based solution. It's dedicated teams and specialized tools ready to make your implementation simple and your experience seamless.


Flexible and Effective Framework

MasterControl provides an effective framework for a company's quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a web-based, centralized location for all documents and data.

Solutions for The Medical Device Industry


MasterControl Development Excellence™ Solution


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


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


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


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


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


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.