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. This proposed regulatory framework is...
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 decisions for an organization. A final...
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, medical device manufacturers are interested...
For medical devices, ISO (International Organization for Standardization) is one of the most significant organizations. ISO issues international standards. Often, national or regional standards organizations adopt the international standards and change their designations. The current international standard for medical device risk management is ISO 14971:2007....
It is likely that you know someone who has received a ligament or tendon replacement, a cornea transplant, or a skin graft. If these tissues were derived from humans, are these products regulated by FDA? This blog will provide an overview of the regulatory framework...
Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. With all the technological advancements in the...
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be seen in every department at those medical device companies. By default, the regulatory affairs functions have been the worst hit and are struggling to soar up...
With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of what has changed in the new EU MDR and how as a Medical Device manufacturer you can best deal with these changes. You can read some...
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests. Upon completion...
The three-year transition period to the EU MDR does not only engage the Regulatory Affairs personnel in Medical Device companies but also the entire business leadership as well. Companies are still in the three-year transition period to comply with the EU MDR. This transition does not...