design control

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…

medical device design control

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…

Quality control team members looking at a computer using medical device design control software.

How to achieve continuous monitoring in medical device design control

Medical device design control is notoriously riddled with errors and inefficiency, but it doesn’t have to be. Continuous monitoring can…

Why design control is essential for medical device development: Overcoming challenges with digital solutions

Discover why design control is essential for medical device development and how digital solutions like Siemens’ PLM for Medical Devices can help overcome common challenges, ensuring safety, compliance and efficiency throughout the device lifecycle.

White female looking at test samples in an incubator

Integrate a concept management system for better medical device design control

Learn more about how to integrate a concept management system in your medical device development process for better design control today.

Design Control: Creating a comprehensive history of design authoring

Today, medical device companies face the ultimate dilemma: how to build a comprehensive product innovation program while avoiding slowdowns. The…

Design Excellence in Medical Device: Comprehensive Risk Management

“traceability, application, & decision support through Requirements, Design, and Verification & Validation”

Design Excellence in Medical Device: Design File Integrity

“accessible, integrated, high quality data throughout the product lifecycle for trusted compliance and product maintenance”

Design Excellence in Medical Device: Robust, Concurrent Design

“enable quick domain specific progress with highly capable design tools for efficient cross-domain workflow merges”