Does your Quality Management System support using a 3D printing process to manufacture a medical device or a component of a medical device? There are a few considerations when using 3D printing in the manufacturing process of a medical device. The...
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and...
As part of our blog series on Artificial Intelligence and Machine Learning Medical Devices, this time we will discuss the FDA’s take on how modifications made to the software after its initial review will be addressed within the SaMD pre-specifications and Algorithm Change Protocol submitted by the...
As part of our blog series on artificial intelligence and machine learning driven medical devices, we discuss the SaMD Pre-Specification and the Algorithm Change Protocol that FDA has crafted for such devices, in this blog. Before a medical device can be marketed in the U.S....
FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking great strides in establishing regulations for the digital health industry that also facilitates research and development while maintaining high quality products. In our...
On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191....