Supporting Software Due Diligence for a High-Risk Medical Device Acquisition
Background A global medical device company was evaluating the acquisition of an international manufacturer developing a high-risk, software-driven implantable medical device. While the acquiring organization had extensive experience within its existing product portfolio, the target company’s technology introduced new complexities related to software, firmware, cybersecurity, and connected medical device functionality. To support its due diligence […]
AI-Accelerated Software Development Meets Regulatory Reality: Preparing a 510(k)-Ready Documentation Strategy
A commercial medical device manufacturer with an established global presence sought regulatory guidance while preparing a new web-based software platform supporting the radiology market. The company generated more than $100 million in annual revenue and marketed products in over 40 countries. To accelerate development, the company leveraged artificial intelligence to generate both software code and […]
