Quality Change Management

Design Control

Design Control

Regulated companies must create and maintain plans that describe or reference their product design and development activities. This means a design control system is essential for these companies.

Medical device and other health care product manufacturers are required to manage many documents to meet design control guidelines. Speed to market is critical. Automating your design history file (DHF) and document management processes gives you an advantage. MasterControl's design control software interconnects data, processes and people. Overall, it enables companies to achieve compliance in less time, with less effort and at a lower cost.

MasterControl Medical Device (DHF) JumpStart™

Revolutionize the way you manage design controls.


Ensuring Product Quality and Compliance


Medical device manufacturers must adhere to strict regulatory policies. The products also need to provide the best customer experience. Achieving these outcomes begins with the design control procedures. MasterControl's design control system enables you to consistently produce high-quality, compliant products.


An Audit-Ready Design History File


Changes to regulated products involve a lot of documents and stakeholder meetings. They also involve revisiting your design history file (DHF) to prepare for audits. MasterControl's design control system puts you a step ahead of any audit because all your documents and objective evidence are electronic and are easily found in one location.


Efficient Document Control Systems Accelerate Compliance


Missing documents, incomplete or inaccurate information and unapproved document changes cause setbacks and delay product releases. Life sciences companies are avoiding these costly issues by using document control software. 

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A Design History File That Exceeds Expectations

Losing a requested design history file (DHF) or specific materials in the file can result in costly setbacks. With MasterControl, all documents and artifacts, such as the design and development plan and design input and outputs, are in a central location. This makes it easier to keep the contents up to date and provide a complete DHF during audits.


Seamless Communication

Paper-based change control management creates roadblocks. Lack of business unit interaction, slow document reviews and missing information causes delays. MasterControl’s design control software unifies companies, improves communication, boosts efficiency, and keeps product releases on schedule.

Avoid Design Control Warning Letters

Maintain a competitive edge with effective design control procedures.

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