Blogs

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...

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...

Happy World Immunization Week! Lately, we’ve heard about outbreaks of diseases that we previously thought were preventable. What are some of the latest numbers and what can we do? This week’s blog is a snapshot of the impact of vaccines...

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....

Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device?  If your Risk Management process is not integrated with HFE, how and when to integrate it into the product development process can be important...

Randomized controlled trials have long been the gold standard for collecting clinical data on investigational medical devices. However, with the increasing costs of conducting trials, difficulty in tracking long-term outcomes, and sometimes mismatch of clinical trial data with practical experience,...

With the initial Brexit plans derailed and the deadline now being extended to April 12th, the trade and manufacturing industry is in a state of chaos. The constantly changing regulations have put the stakeholders in a difficult situation. In preparation...