Design Control for Medical Devices: Build safer devices, prove compliance 

In medical device development, every design decision has implications for patient safety, clinical efficacy and regulatory approval. Global frameworks like US 21 CFR Part 820 and EU MDR/IVDR mandate rigorous design control, ensuring that devices are built safely, perform as intended and are backed by complete, traceable documentation. 

Despite clear expectations, execution often isn’t. Many organizations still rely on disconnected systems to manage design inputs, risk analyses, test results and documentation. These gaps make it harder to prove compliance, catch errors early and confidently move products to market. 

To meet today’s expectations for medical device compliance, teams need more than good intentions and manual traceability. They need a system-level approach—one that embeds design control and risk management directly into the development process from the start. 

What effective design control looks like in practice 

At its core, design control ensures that medical devices are safe, effective and compliant with regulatory requirements. It governs every stage of the product lifecycle: planning, inputs, verification, validation, transfer and ongoing changes. 

Well-executed design control enables teams to: 

• Maintain bidirectional traceability across requirements, risks and test results 

• Detect design issues early, before they become costly rework or audit flags 

• Streamline creation and maintenance of the Design History File (DHF) 

• Simplify design reviews and support parallel design documentation analysis 

• Reuse validated components and processes to accelerate development 

But achieving this level of control with siloed tools, spreadsheets or static documents is nearly impossible. 

Embedding compliance into development processes 

Too often, design control is treated as a separate documentation effort that happens after the fact. Engineers focus on solving technical problems while quality teams try to backfill the compliance story, introducing delays, gaps and risk. 

Instead, leading medtech companies are shifting to a digital approach. With solutions like Siemens’ Polarion for Design Control, organizations can manage product development and compliance together in a single, integrated environment. 

This system-level approach allows teams to build compliance into the development process from the start. Requirements, risks and test cases are managed centrally and connected dynamically. Design reviews become faster, more meaningful and easier to audit. And DHF creation is automated—not manually assembled at the end. 

Explore how Polarion supports this shift in our Design Safety & Effectiveness ebook. 

Case in point: driving speed and clarity at Dentsply Sirona 

For Dentsply Sirona, a global leader in dental technology, design control was a way to bring clarity, consistency and collaboration to their development process. 

Using Siemens’ Polarion solution, Dentsply Sirona integrated design documentation and compliance activities into one digital system. The result was a streamlined lifecycle with clear traceability, audit-ready files and a more transparent process for all stakeholders. 

This change is not unique to only them. Other companies like iThera Medical also leverage Siemens’ solutions to confidently accelerate market entry, improve documentation and simplify regulatory submissions. 

Avoid compliance bottlenecks 

Regulatory demands will only increase in the coming years. Emerging standards for digital traceability, AI-enabled devices and real-time monitoring will put new demands on design teams. Manual compliance strategies simply won’t suffice. 

To meet these challenges, medical device manufacturers must adopt tools that help them manage complexity and incorporate quality into processes from the start, rather than tacking on compliance later. Siemens’ Design Control solutions provide the infrastructure to do exactly that. 

Built specifically for regulated industries, Polarion helps organizations: 

• Enforce structured processes for design and risk management 

• Maintain live traceability from requirements to release 

• Automate documentation for design reviews and DHF generation 

• Enable real-time collaboration across teams and disciplines  

Want to make design compliance a competitive advantage? Explore Siemens Design Control solutions. 
 
For a deeper dive into Design Safety & Effectiveness, read our ebook.