The journey of a medical device from concept to commercialisation involves a series of iterative stages, each with its unique challenges and requirements. Among these stages, design transfer stands out as a critical milestone, marking the transition of product designs from the realm of research and development (R&D) to the realm of manufacturing.
Design transfer encompasses a range of activities, including documentation, process validation, risk management, and regulatory compliance, all aimed at ensuring the seamless transition of designs into commercially viable products.
What is design transfer?
Design transfer in medical devices refers to the process of translating product design into production specifications to ensure the device is manufactured accurately and consistently.
Design transfer involves detailed documentation, verification, and validation to confirm that the design outputs meet the intended design inputs and regulatory requirements. Effective design transfer ensures that the final product aligns with the original design and performs safely and effectively in its intended use.
Documentation requirements
Documentation is a cornerstone of design transfer, serving as the meticulous blueprint for manufacturing processes. It ensures consistency, traceability, and most importantly, compliance with regulatory requirements. In the context of design transfer, the documentation requirements are not just a checklist, but a comprehensive set of deliverables. These include design history files (DHF), device master records (DMR), and device history records (DHR) (or alternative design and development records as specified in the Design and Development plan). Each of these documents captures essential information related to product design, specifications, manufacturing processes, and quality controls, providing a thorough record of the product’s journey from concept to commercialisation.
- Design history file (DHF): a comprehensive record that documents the evolution of the product design from initial concept to final specifications. It includes design inputs, design outputs, design verification and validation activities, design changes, and risk management documentation, providing a detailed record of the product development process.
- Device master record (DMR) consolidates all specifications and procedures required to produce the medical device. It encompasses drawings, bill of materials (BOM), manufacturing instructions, inspection criteria, packaging requirements, and labelling specifications, serving as a centralised repository of information for manufacturing personnel.
- Device history record (DHR) documents the production and inspection history of each manufactured unit, including traceability information, inspection results, deviations, and corrective actions. It provides a comprehensive audit trail of the manufacturing process, facilitating post-market surveillance, quality control, and regulatory compliance.
The DHF, DMR, and DHR originate from the U.S. Food and Drug Administration (US FDA) Quality System Requirements (QSR) language. Each regulatory system has its own terminology for these documents, and the content and structure of the documentation may change in different countries or regions.
Effective documentation management is essential for ensuring the integrity, accessibility, and accuracy of design-related information throughout the design transfer process. Document control procedures, version control mechanisms, and electronic document management systems (EDMS) are commonly employed to manage documentation workflows and ensure compliance with regulatory requirements.
Process validation in design transfer
Process validation is a critical component of design transfer in medical devices, ensuring that manufacturing processes consistently produce products that meet predetermined specifications and quality standards. During design transfer, process validation verifies and documents that the production processes can reliably produce devices that conform to design requirements. This step ensures that any potential issues are identified and addressed before full-scale production, guaranteeing that the final medical devices are safe, effective, and compliant with regulatory standards.
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.
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.
Process Validation: Ensures that the entire manufacturing process, supported by process controls, reliably produces products meeting all requirements.
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.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
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.