What are design controls?
Design controls are a systematic framework of practices and procedures applied during medical device development to ensure that devices meet user needs and intended purposes and comply with regulatory requirements.
Design controls provide evidence that manufacturers have designed medical devices that are safe and perform their intended purposes
These controls are mandated by regulatory authorities to ensure the effectiveness, safety and quality of medical devices
The definitions and requirements for design controls in US FDA regulations and ISO 13485 are very similar. Both regulations expect thorough documentation, records, and traceability between design controls to be maintained throughout the product development process.
Design controls in the medical device development process
User requirements are directly related to the device’s intended purpose. User requirements or user needs form the basis for establishing design inputs and provide the criteria against which the device’s functionality and performance are measured.
User needs must be documented in a structured format. This documentation should be comprehensive and specific, covering all aspects of use and performance.
Design inputs (also known as technical specifications) define the physical, functional, and performance requirements of the device based on user needs and other resources, including industry standards, regulations, clinical, performance, and safety data, and competitive products.
Much of the data that is used to formulate design inputs is generated during the early-stage research and feasibility studies. Investing in systematic, comprehensive early-stage research processes helps streamline design input development. It is typical for one-third of the development timeline to be devoted to formulating design inputs.
Design inputs should be objective and measurable.
Verification ensures that design outputs meet design inputs through rigorous testing and analysis. Verification is proof that the medical device has been designed correctly and meets the specifications in design inputs.
Design verification requires careful planning to identify the best methods to prove that design outputs meet design inputs. Planning should always be completed before conducting tests, inspections, and analyses. Verification documentation can include test plans and protocols, results and data analysis. Verification reports should demonstrate that design outputs achieve compliance with design inputs.
Design transfer includes all the activities necessary to ensure the design accurately translates into production specifications, enabling consistent manufacturing. The design outputs are converted to the production environment and used by production personnel to assemble devices.
Although design transfer is usually depicted at the end of the design controls, it typically starts in parallel with design inputs. This ensures the design can be manufactured at the appropriate scale and quality standards. Further, validation studies are conducted using product units made using production-equivalent documentation and processes. These production units are then tested with end users.
Formal design reviews are assessments performed at critical stages in the lifecycle to determine whether the device meets design inputs and user requirements and identify any development issues. They ensure all requirements are met before proceeding to the next stage. Design reviews are cross-functional, multi-disciplinary team reviews that evaluate design and development progress and conformance. Review outcomes and action items are documented as part of the development process.
The Design Transfer Design Review is the final review that ensures everything needed for production is ready and done. Completing Design Transfer signifies that the medical device is prepared to exit product development and officially enter production.
Conclusion
Design controls are necessary for any medical device development project. They enable developers to systematically manage and document the design process, ensuring that all requirements are met and that the final product is safe, effective, and compliant with regulatory standards. Design controls are further improved by using a traceability matrix to map and track the relationships between various design and development process elements. This ensures that all requirements are addressed, verified, and validated throughout the design, implementation, and testing phases.
Document design controls and build a traceability matrix early in the project. Update it regularly throughout the development process. This will help create documentation as the project progresses and identify issues earlier in development.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
United State of America (USA):
Food and Drug Administration (FDA) guidance document:
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- Design and Development is included in the QMS Requirements: Chapter I, Article 10(9)(g)
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- Design and Development is included in the QMS Requirements: Chapter I, Article 10(8)(g)
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
- Technical documentation requirements are specified in the QMS requirements PART 820.30 Quality System Regulation Procedures: Design Controls
International Standards:
ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes, Section 7.3. Design and Development
Change Control: The systematic process of managing and documenting modifications to a device or its manufacturing process to ensure that all changes are assessed, approved, implemented, and tracked in compliance with regulatory standards and quality management systems. This is also known as Change Management.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Design Control: A systematic process that ensures a device is designed to meet user needs and intended uses.
Design and Development Plan: A comprehensive document outlining the systematic process and stages, including timelines, responsibilities, and resources, required to bring a medical device from concept to market-ready product, ensuring compliance with regulatory standards.
Design Freeze: The point in the medical device development process where the design is finalised and no further changes are allowed, ensuring a stable basis for validation, regulatory submission, and production.
Design History File (DHF): A compilation of records that describes the design history of a finished device.
Device Master Record (DMR): A comprehensive collection of documents and records describing the medical device’s design, manufacturing, and quality control processes.
Device History Record (DHR): Report confirming that the device is produced according to the specifications in the DMR.
Design Inputs: The physical and performance requirements of a device that are used as a basis for device design. Also known as Technical Specifications.
Design Outputs: The results of a design effort at each design phase and at the end of the total design effort used to evaluate conformance to design input requirements.
Design Review: A formal evaluation process to assess the completeness, feasibility, and compliance of a device’s design with specified requirements (design inputs).
Design Transfer: The process of transitioning a product’s design from development and manufacturing into production while ensuring all specifications and requirements are met.
Design Verification: The process of ensuring that design outputs meet design inputs.
Design Validation: The process of ensuring that devices conform to defined user needs and intended uses.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Technical Specifications: Detailed descriptions of the requirements, characteristics, and standards that a product, service, or system must meet or adhere to, ensuring clarity and consistency in its design, production, or implementation. Also see Design Inputs.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
Traceability Matrix: A document that maps and links requirements throughout the development lifecycle, ensuring that each requirement is tested and validated, thereby demonstrating compliance with regulatory standards.
User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.