Design smarter: How to ensure medical device design control and process compliance
In medical device development, safety isn’t optional. It’s mandatory. Regulations like FDA 21 CFR Part 820 and EU MDR/IVDR enforce rigorous design control practices to protect patients and ensure consistent product performance.
Yet compliance remains a persistent challenge. Design inputs, risk documentation, validation results and change requests are often scattered across disconnected tools, managed by siloed teams. Core deliverables such as the Design History File (DHF) or Device Master Record (DMR) can become incomplete, outdated or hard to track. And if an audit arrives—or a field issue surfaces—these gaps can translate into lost time, reputational damage or product recall.
To operate at speed without sacrificing compliance, manufacturers need a modernized approach, one that leverages digital systems to manage complexity and reinforce quality at every stage.
Why design control is mission-critical in today’s medtech environment
Medical device design control isn’t a regulatory formality. It’s the foundation of safe, efficient product development. Done right, it provides traceability, prevents late-stage issues and supports faster approvals. But with today’s increasingly complex devices and multidisciplinary teams, sustaining traceability is no small feat—especially when working across fragmented systems.
Regulators are also raising the bar. It’s no longer enough to prove a device works; manufacturers must demonstrate that the entire development process is systematic, deliberate and aligned with risk.
That’s where digital tools can help. Siemens’ Design Control for Medical Devices tools enable teams to embed compliance directly into their workflows, rather than managing it after the fact.
Enabling better collaboration and compliance with digital systems
Digital design control transforms how teams work. With Siemens’ PLM for Design Control, manufacturers can accurately capture DHF and DMR content using configurable templates, gain real-time visibility into design status and risk and reuse validated inputs to accelerate iterations. It creates shared context across R&D, quality, regulatory and manufacturing teams, making development more transparent, accountable and efficient.
From fragmented workflows to coordinated teams: Dentsply Sirona’s journey
Dentsply Sirona, a global dental technology leader, faced a familiar challenge: ensure compliance while improving collaboration. By implementing Siemens Polarion, the company did more than just meet FDA and IEC 62304 requirements, it increased transparency across its entire product lifecycle.
“Dentsply Sirona uses Polarion solutions not solely to achieve compliance with medical device regulations like FDA or IEC 62304, but to make the development process lifecycle more transparent for all parties involved,” said Michael Dalpiaz, project coordinator for Dentsply Sirona.
This shift empowered teams, reduced rework and shortened time to market—all while maintaining regulatory confidence.
What defines a best-in-class design control system?
A modern design control solution supports the full development lifecycle, from design planning and risk management to validation, transfer and change control. It maintains a living record of the product that’s always audit-ready, with traceability that connects requirements to risks, test cases and results. This enables teams to identify issues early and resolve them before they escalate.
Rather than bolting compliance on at the end, teams can build it in from the start. Real-time collaboration, automated documentation and unified visibility across functions streamline both submissions and development—reducing cost, accelerating delivery and improving quality.
Confidence built on compliance: iThera Medical’s success
For iThera Medical, compliance was a launch-critical requirement. Using Siemens’ solutions, the team aligned processes, improved documentation and brought a complex product to market with confidence.
“Polarion ALM provides us with a solid foundation for efficient engineering information management. We reduced the time spent searching for data by more than 65 percent.” Read the full iThera case study
Take the next step: Make compliance a strategic advantage
Staying compliant in today’s medtech landscape requires systems that provide clarity, rigor and visibility, every step of the way.
With Siemens’ Design Control solutions, manufacturers don’t have to choose between innovation and compliance. They can advance both. Because when quality is embedded into the process—not added as an afterthought—it doesn’t just protect the business, it propels it.
Explore how digital design control helps you stay compliant and competitive.
