Mitigating risk through consistent testing.

Agile Medical Software Development

Agile is a type of risk management that mitigates risk by testing after each small change in your medical device.  Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality.  The increase in complexity makes it extremely important to test your device after every small change to your software, in order to mitigate risk.

• Design History File (DHF) Remediation
• Get products to market quickly and cost efficiently
• Utilize state-of-the-art tools and electronic test equipment
• Proven track record of FDA/CE approvals
• Software verification and validation testing

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools and equipment. Our team will help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals. We can help you move toward your best practices, such as leveraging safety assurance case principles to clearly demonstrate the safety of your medical device product.