NEMA Medical Image Management SW Guidance

The National Electrical Manufacturers Association (NEMA) has published a guidance document on supply chain best practices for electrical equipment and medical imaging manufacturers to minimize the possibility that bugs, malware, viruses, or other exploits can be used to negatively impact product operation. The document is a representation of identified best practices that vendors can implement as they develop, manufacture, and deliver products as part of the supply chain. The document addresses supply chain integrity through four phases of the product life cycle: manufacturing and assembly, tamper-proofing, security development life cycle, and decommissioning/revocation. Although directed at Medical Image Management products, some of the content could be of value to consider for other types of medical device software.

The NEMA guidance document is available at the link provided: Supply Chain Best Practices

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.