In medical device development, every design decision has implications for patient safety, clinical efficacy and regulatory approval. Global frameworks like…
In medical device development, safety isn’t optional. It’s mandatory. Regulations like FDA 21 CFR Part 820 and EU MDR/IVDR enforce…
Medical device design control is notoriously riddled with errors and inefficiency, but it doesn’t have to be. Continuous monitoring can…
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.
Learn more about how to integrate a concept management system in your medical device development process for better design control today.
Today, medical device companies face the ultimate dilemma: how to build a comprehensive product innovation program while avoiding slowdowns. The…
“traceability, application, & decision support through Requirements, Design, and Verification & Validation”
“accessible, integrated, high quality data throughout the product lifecycle for trusted compliance and product maintenance”
“enable quick domain specific progress with highly capable design tools for efficient cross-domain workflow merges”
