This article highlights key steps and considerations for medical device companies to establish effective design controls.
Table of Contents
Design controls are a crucial aspect of the medical device development process.
They ensure that medical devices are safe, effective, and meet the intended use requirements.
Implementing robust design controls is not only a regulatory requirement but also a critical factor in achieving successful product development and commercialization.
Understanding Design Controls
Design controls are the formal processes mandated by the US medical device regulation FDA 21 CFR 820.30 and the Quality StandardSO 13485:2016.
However, the requirements are country/region specific.
Design control a systematic approach followed by medical device manufacturers to ensure that the design outputs meet the user needs and intended use of the device in the region where it is being marketed.
Key components of design controls include design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes.
The Design History File (DHF) should contain all the design controls’ “evidence”.These records are maintained to establish effective compliance with ISO 13485 and 21 CFR 820 requirements.
Regulatory Requirements
First step for medical device manufacturers is to get familiar with the regulatory framework governing medical devices of their target market.
For example, in the United States, the Food and Drug Administration (FDA) requires compliance with the Quality System Regulation (QSR) outlined in 21 CFR Part 820.
Other regions, such as the European Union, have their own set of regulations, such as the Medical Device Regulation (MDR). Understand the specific design control requirements outlined in these regulations to ensure compliance.
The design process depends heavily on input from the designer and output verification.
Process of Implementing Design Control
Design and Development Planning
Create a comprehensive plan that outlines the design and development activities, responsibilities,risk management (ISO14971) and timelines for each stage of the process. Regularly review and update the plan as the project progresses.
Design Input
Identify and document the user’s needs and intended use of the medical device. Translate these requirements into specific design inputs, such as performance criteria, safety requirements, and usability considerations. Ensure that design inputs are clear, measurable, and traceable throughout the development process.
Design Output
Document the design outputs, like specifications, drawings, and manufacturing instructions. They consistent with the design inputs and support the device’s intended use.
Establish mechanisms to review, verify, and validate the design outputs before proceeding to the next stage.
Design Review
Perform structured design reviews, involving cross-functional teams, at defined stages to assess progress, identify issues, and ensure compliance; document findings, actions, and design revisions.
Design Verification
Perform design verification to ensure that the design outputs meet the defined design inputs.. Use appropriate statistical techniques, sample sizes, and acceptance criteria to demonstrate compliance. Document the verification activities and results thoroughly.
Design Validation
Validate the device by testing it in a real or simulated environment to ensure it meets user needs and safety standards. Gather data, document the process and outcomes, and address any necessary improvements.
Design Transfer
It ensures a smooth transition from design to manufacturing, verifying consistency and documenting the process.
Design Changes
Establish a thorough change control process for design changes, defining evaluation criteria, and documenting all changes with safety, efficacy, and compliance considerations.
Conclusion
In today’s dynamic business world, adaptability, innovation, and a culture of continuous learning are vital for success. Medical Device ompanies need to harness data-driven insights.
For doing so, medical device companies need to focus on design controls.
Compliance with country spcific design control requirements can help manufacturers to easily manage the lifecycle of their device and get marketing approval from the concerned regulatory authority
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
