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…

A man on a computer conducting CAPA processes with digital software tools.

Enhancing CAPA process with digital quality tools

A quality-driven approach for MedTech manufacturers aiming to improve continuous enforcement and CAPA processes using Teamcenter Quality.

Meeting medical device regulations with quality process efficiency

Overcome medical device regulation challenges with quality process efficiency. Siemens’ closed-loop quality management solution streamlines design, ensures compliance and enhances product quality.

A group of people talking to a regulatory board about medical device compliance.

Implementing information transparency solutions to prove medical device compliance

To prove medical device compliance, manufacturers are responsible for providing a wealth of information to the appropriate regulatory bodies. When…

Track quality and medical device compliance data with a digital framework

Between 2018 and 2022, over 13,000 medical devices were recalled in the United States alone. As 90% of medical device…

Two medical device engineers in a manufacturing facility.

Bridge the gap between data and collaboration in medical device manufacturing

Streamline your medical device manufacturing with digital workflows, simulation and a connected digital thread. Boost productivity, enhance collaboration and ensure compliance. Explore how Siemens Operational Excellence tools can transform medical device manufacturing.

Conquer medical device development complexity with advanced modeling tools

Streamline medical device development with advanced virtual design tools. Simplify complexities, accelerate innovation and ensure regulatory compliance. Read the blog today.

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…