"Are you ready for FDA" is a single self-assessment consists of multiple questions covering the complete ISO 13485. This also includes questions to cover the readiness for SaMD manufacturers who use Artificial Intelligence and Machine Learning (AI/ ML) as per FDA’s recent guideline. Depending on your response on the state of your product and company – pre-market or post-market as well whether your device uses AI/ ML, the assessment will guide you to answer only the questions relevant for you.
Nine Questions for Medical Device Software and SAMD Manufacturer
In this article we shall lay out various standards and guidelines as they apply to both Medical Device Software and SaMD. In short, we shall call them together as Medical Device Software as it covers a broad swath of medical device software from low criticality information only software to highly critical software for implants and invasive devices.
Convert Data to Action - Fast and Easy!
As data scientists we are often asked to find the main factors that cause a particular outcome. From business point of view predicting that outcome is important. But even more important is to determine the factors influence that outcome so that the business can control the outcome by modifying those “causing” factors; this is provided by a “causal model”. A predictive model does not provide the actionable insights; a causal model does.