Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...
Agile developments products and turnkey device assembly serving the electrophysiology and interventional cardiology catheter markets Agile represents the tenth add-on acquisition for Resonetics since ...
As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...
The world of medical devices is rapidly changing. In place of disconnected, simple medical devices, a new world of complex software both on and off the now-connected device is providing a larger ...
Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and ...
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...
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Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...
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