The FDA released a guidance document on the non-clinical testing and clinical considerations of ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation’. The document can be downloaded from the FDA website. One point of particular interest comes from the software section, where the FDA states that “We generally consider the software for...Read More
In a release from The Cybersecurity and Infrastructure Security Agency (CISA) on July 21, 2021, it was announced that the Common Weakness Enumeration (CWE) Top 25 list has been updated from the previous 2020 version. The CWE Top 25 is a list that uses real-world data from the National Vulnerability Database (NVD) to identify current...Read More
As the use of Artificial Intelligence (AI) and machine learning methods expand in medical devices and HealthIT software, an oft asked question is whether the data sets used for training should be retained as part of the design history file (DHF) or other long term storage mechanisms. SoftwareCPR partners Alan Kusinitz, Sherman Eagles, John Murray,...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.