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...
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 for what appears to be...
Does your medical device Risk Management process include Usability / Human Factors Engineering (HFE)? For many devices, the manufacturer must have a process to evaluate the Usability of a medical device as it relates to safety. This can be accomplished by adding processes to, or integration...
3D printing has a multitude of applications in the medical device field. Right from the inception of the additive manufacturing technique, engineers have been working on how this technology can serve the health care industry. Additive manufacturing has the capability to manufacture devices that match...
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...