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Design control guidance for medical device manufacturers

Reading time: 6 minutes

Design control guidance for medical manufacturers enables a digital transformation of the design process that is crucial to managing the complexity of today’s market As patients and healthcare providers expect state-of-the art technology, usability, flexibility and effectiveness in medical devices, compliance needs to be at the heart of every step of the design process.

This ebook on Design Excellence provides an overview of how you can harness the complexity of integrated, multi-disciplinary product design to meet consumer demands and regulatory requirements for safe, smart, and connected products.

Medical device verification and validation software

Explore emerging trends in medical device design and manufacturing including a new focus on digital evidence for device verification and validation. Find out how Siemens Design Excellence helps optimize the design and performance of competitively differentiated, premium-value devices.

This medical device verification and validation software combines digital evidence capabilities with the use of simulation technologies for virtual, digital performance testing of devices. You are enabled to produce evidence for decision support and implement verification and validation activities that reduce costly physical tests and iterate quickly and efficiently using scalable, cloud-based collaboration technology.

Master medical device product development

Your organization needs to master medical device product development to thrive in a highly complex industry. Expanding competition means new products need to be compliant and get to market faster. With Design Excellence, you have a holistic digital solution to integrate best practices into your product development with capacity for advanced design and evidence re-use, collaborative design, design file integrity, comprehensive risk management and digital evidence to reduce costly physical tests and iterate quickly.

Robust medical device risk management across all disciplines

Design Excellence empowers robust medical device risk management across all disciplines. As medical device manufacturers are being challenged to increase or at least maintain their market share in this highly competitive industry, the trend to value-based healthcare and predictable delivery networks forces them to guarantee compliance while increasing speed to market and reducing cost. In this situation, with the trend toward increasingly complex medical devices that are easy to use, smart and connected, it is critical that risk management be integrated across all disciplines of your operation.