Design Control Software for Medical Device Manufacturers

Medical device creators and manufacturers have a lot on their plate. Not only are they creating potentially life-altering equipment, they are working in an industry where safety, documentation and regulatory precision are essential.

Warning letters from the U.S. Food and Drug Administration (FDA) to medical device manufacturers remained high in 2024, most related to deficiencies in design controls.

The right design control software can help manufacturers avoid potentially costly mistakes that result from inadequate design controls, incorporating the structure, traceability and collaboration tools needed to meet regulatory requirements efficiently.

This article provides an overview of design control software, how it simplifies medical device compliance with FDA 21 CFR Part 820 and ISO 13485, and the best practices for creating an effective and value-added design control environment.

Contents

What is design control software?

Regulatory requirements for design control

The design control process

How does QMS software support design control?

Key benefits of design control software

Streamline compliance with design control software

What is design control software?

Design controls are quality and regulatory requirements that are incorporated into the product design and development process to ensure that a medical device is safe, effective and meets its intended use. Medical device manufacturers must demonstrate functional design control to be able to bring their product to market.

Design control software automates and organizes the documentation, reviews and approvals required to meet these regulations. It serves as a central hub for managing every stage of device design, from initial concept to market release, while ensuring compliance and collaboration across cross-functional teams.

Integrated with a quality management system (QMS), design control software also improves traceability, helps teams stay audit-ready and connects design activities with risk management, document control and supplier oversight.

Regulatory requirements for design controls

FDA 21 CFR Part 820 regulations and ISO 13485:2016 standards require medical device manufacturers to maintain formal design control procedures.

These frameworks emphasize:

• Documented planning and input/output management
• Continuous verification and validation
• Thorough design review and approval
• Comprehensive design and development files
• Ongoing risk management across the device lifecycle

The goal of compliance is to ensure that user needs are accurately reflected in design inputs and that outputs meet those specifications through documented testing and review.

The design control process

Once user needs are defined and documented, the design control process can be broken down into the following steps:

1. Design and development planning

During this phase, detailed plans for how you will design and develop your device are created. This involves outlining the steps to be taken and in what order, and assigning responsible parties to each step. Design plans must be documented and documentation made readily available, with a system in place for tracking changes and ensuring use of the most up-to-date documentation.

2. Design input

Design inputs is one of the most important phases of design control and should be given thorough attention. Medical device designers must define what the device will do for the end user and how it will work, including how it might integrate with other systems. Input requirements must be documented, reviewed and signed off on by a designated authority.

3. Design output

Design outputs are the result of the planning and inputs phases, usually in the form of a model or related documentation, such as drawings or engineering plans. Outputs must be specific enough for a manufacturer to use in production. Output documentation is also subject to review and approval with signature by a designated authority necessary.

4. Design review

This is a formal review of the device’s design that involves “representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility,” plus any necessary specialists. The goal is to ensure that the design and design plan are viable. All data from the design review, including results and participants, must be documented and included in the design and development files.

5. Verification

Design verification involves testing device components to ensure design output meets design input requirements. Results, dates and reviewer identification are documented and included in design and development files.

6. Validation

The design validation phase ensures that produced devices conform to defined user needs and intended uses. Validation involves testing of initial devices under actual or simulated conditions, and include packaging, transportation and storage. Any problems are evaluated and addressed.

7. Design transfer

The design transfer phase requires device manufacturers to develop and then maintain procedures to ensure that appropriate specifications are provided to all parties involved in producing the device.

8.Design changes

Procedures must be established for tracking any changes that are necessary to make to the design, including documentation, validation, review and approval of changes prior to implementation.

9. Documentation

There must be detailed documentation of processes, procedures, responsibilities and data to demonstrate compliance and traceability.

How does QMS software support design control?

Design control software automates the more tedious aspects of medical device design, systematically addressing compliance and freeing up engineers and manufacturers to focus on more productive activities.

Integrating design controls with quality management functions affords a host of features that help manage the intricate processes of design control. Key features include:

Automated document management

Documents are centralized and can be easily shared for review and approval, with revision-level controls and built-in electronic signatures. DHFs are easily maintained and updated. Tools found in QT9 QMS' Document Control module simplify approvals, maintain electronic signatures and enable read-only sharing links for auditors, customers or suppliers.

Change control

Integrated change control systems make it easy to initiate, track and document changes while automatically updating related records in the DHF.

Risk management

Link design control and risk management processes to document risk analysis, mitigation steps and results. This integration provides verifiable proof of proactive risk management.

Structured risk management systems can easily link with design control applications for verifiable proof that a manufacturer has appropriately evaluated and taken steps to mitigate any potential or unforeseen risks in the product design and development plan.

Identifying and mitigating risks early in the design process can be critical to preventing costly errors and ensuring patient safety. Design control software facilitates comprehensive risk management by providing tools for risk assessment, analysis and mitigation.

Supplier management

Supplier management applications assist in ensuring suppliers are appropriately qualified for their role in the manufacturing process and provide a traceable system for tracking supplier inputs and activities. Maintain qualified supplier lists, track performance and ensure supplier inputs meet specifications. Integration with design control workflows adds visibility and traceability to outsourced components or services.

Key benefits of design control software

Utilizing design control software in your medical device development offers an array of transformative benefits that pave the way to bringing your device to market.

Save time and money

Design control software streamlines the entire product development lifecycle, from conception to release. By automating documentation tasks, facilitating reviews and collaboration, and providing real-time visibility into project status, device manufacturers can gain efficiencies that significantly reduce the amount of time and effort required to bring a medical device to market.

Enhance traceability

Automating documentation and integrating quality applications into your design controls establishes and simplifies traceability among the various phases of the design process. This ensures that changes, revisions and updates are documented and tracked systematically, and provides a clear path for regulatory submissions and audits.

Improve collaboration

With a regulatory mandate to involve diverse teams in the product design process, effective collaboration between these teams is important. Design control software acts as a centralized platform where engineers, quality and regulatory experts and other stakeholders can share insights and align efforts. Features such as document sharing, task assignment and real-time communication tools, foster efficiency, synergy and drive innovation.

Strengthen regulatory readiness

Design control software alleviates the burden of regulatory compliance by integrating built-in templates, workflows and audit trails aligned with FDA and ISO regulations. By automating compliance processes and documentation, it ensures that companies adhere to regulatory requirements throughout the design and development phases. This proactive approach not only minimizes the risk of regulatory setbacks but also instills confidence among stakeholders and customers in the safety and quality of the final product.

Support data-driven decisions

Design control software empowers companies through access to real-time data, analytics and insights that enable informed decision-making at every stage of the design process. By aggregating and analyzing data from various sources, including design inputs, test results and customer feedback, design control software can provide stakeholders with valuable insights into product performance, market trends and customer preferences. Armed with this actionable intelligence, companies can make data-driven decisions that optimize product design, mitigate risks and maximize market success.

Streamline compliance with design control software

Adopting design control software, especially as part of an integrated QMS, helps medical device manufacturers improve efficiency, ensure compliance and bring innovative products to market more quickly.

Automating and streamlining the intricate processes involved in design control, enables you to more easily meet FDA and ISO requirements, while fostering a culture of quality and collaboration.

More than ever, success in the medical device industry requires the ability to maintain high quality and regulatory standards in the most efficient and cost-effective way possible. Investing in design control and quality management software makes it considerably easier to reach these goals.