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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)

Design Control Solutions

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

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)

Case study

iThera Medical

Case Study

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.
Ingmar Thiemann, VP, Quality Management and Regulatory Affairs, iThera Medical
Enhance design control

Explore our resources library

Make the design control process more effective to master safety, compliance and monitoring of device design.

A group of engineers wearing lab coats looking at a computer screen.

Optimize device lifecycle with design control solutions

Product lifecycle management

Requirements and verification management

Application lifecycle management

Systems engineering

Learn more


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

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