Medical Device Digital Thread
Medical Device Design Control
Tackle the complexity of medical device design control and effectively manage safety, compliance and monitoring throughout the lifecycle by enabling comprehensive digital traceability and interconnected data analysis.
Accelerate your design control process today
Ensuring safety, compliance and monitoring in medical device design control is crucial for risk mitigation and efficacy. To overcome complexities in data and personnel, manufacturers must prioritize safety and efficacy through digital traceability, compliance via efficient design file management and continuous monitoring with interconnected data analysis.
Improve design speed and efficiency with design control
Deploy an integrated approach for enhanced design control and risk management to ensure your device design is safe and effective for patients and users, compliant with standards and continuously monitored throughout the lifecycle.
Faster time-to-market
Save time creating compliant documentation for audits using an application lifecycle management (ALM) platform. (iThera Medical)
Unifed solution for all product development phases
Utilize a fully unified end-to-end solution covering all major phases from requirements to testing. (Dentsply Sirona)
Lower compliance documentation time
Reduce compliance documentation time by 80% with Polarion. (Sonova)
Enhance design management by using design controls
Navigate the complexities of design control for medical device development and manufacturing with a proven digital partner. Optimize processes, become data-driven and increase engineering efficiency and speed across the device lifecycle using our integrated design control solution.
Enable complete digital traceability, ensuring safety and effectiveness, by integrating design elements, adhering to regulatory compliance and automating data flow throughout the design process.
- Deconstruct documentation into data elements
- Automate trace matrixes to eliminate manual documentation relationships and leverage logical data flows
- Implement comprehensive traceability
Achieve continuous monitoring and ensure efficient and compliant medical device design processes by interconnecting data, enabling parallel documentation authoring and analysis, and establishing dedicated platforms for modular reuse of requirements, risk analysis and testing.
- Interconnect data for parallel authoring and analysis
- Establish dedicated platforms to enable modular and discrete reuse data
- Optimize the time spent on rework and corrective actions
Ensure design control process compliance by implementing effective design file management throughout the development from Design History File (DHF) to design transfer.
- Accelerate production implementations and validation
- Clearly identify and track what has been provided to regulators
- Facilitate accurate communication and collaboration between teams
Design control solutions for medical devices
Less time spent on documentation
Reduce the time required to create, review and assemble documentation for regulatory approval. (Sonova)
Savings in hunting for data
Save time searching for data with an information management system for full traceability. (iThera Medical)
Improved compliance management
Achieve compliance regulations with the FDA or IEC 62304 using ALM software. (Dentsply Sirona)
iThera Medical
Boosting engineering information management efficiency reduces time spent hunting for data by over 65 percent
Company:iThera Medical
Industry:Medical devices & pharmaceuticals
Location:Munich, Germany
Siemens Software:Polarion
Polarion ALM provides us with a solid foundation or efficient engineering information management. We reduced the time spent searching for data by more than 65 percent.
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Make the design control process more effective to master safety, compliance and monitoring of device design.
Optimize device lifecycle with design control solutions
Product lifecycle management
Requirements and verification management
Application lifecycle management
Systems engineering
Frequently asked questions
What is design control?
Design control refers to the process of ensuring safety, compliance and continuous monitoring throughout the product lifecycle, involving comprehensive digital traceability, efficient design file management and interconnected data for parallel documentation analysis.
How can establishing design controls improve the design process?
Establishing design controls can improve the design process by implementing comprehensive digital traceability, efficient design file management and interconnected data for parallel documentation analysis. This helps detect errors early, coordinate employees, provide a baseline for periodic review, increase engineering efficiency, prevent costly errors and recalls and enhance quality and features.
What is a quality system?
A quality system is a comprehensive framework that encompasses the entire lifecycle of a medical device, including the development and approval of design inputs, the design of the device and associated manufacturing processes, ongoing changes to the design or manufacturing process and revisiting the design control process multiple times throughout the product's lifecycle.
What is a Design History File (DHF)?
A Design History File (DHF) is a collection of complete and up-to-date information about a medical device's design process. It includes documentation of design inputs, development activities, testing results, design changes and any other relevant information necessary to demonstrate compliance with regulatory requirements.
How can I improve medical device compliance?
To improve medical device compliance, it's essential to implement effective design file management, ensure complete DHF information, use template-driven regulatory records, reinforce collaboration between R&D and production teams and utilize process compliance tools for quick creation and monitoring of DHF, DMR and technical files synchronized with regulatory interactions.
How can I improve my medical device quality management process?
Because there is a large amount of people and information involved in the development phases of medical devices, it is often challenging to implement, monitor and improve them. Deploying an integrated approach for enhanced design control and risk management ensures that device design is safe and effective for patients and users, compliant with standards and continuously monitored throughout the lifecycle. Siemens Design Control for Medical Devices tools enables manufacturers to support traceability and connections, interconnect data and implement efective design file management.
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Read
Infographic | Improve the safety and effectiveness of medical devices with Design Control
White paper | Manage complex design control framework with PLM
Ebook | Improve the design control process with SaaS PLM