Specific Guidelines

In addition to communication approval, you must also complete a Legal/Medical/Regulatory approval (L-M-R process). Please check with your local organization about the details of this process.

In either case, contact your local legal department.

• There are Medical Software Guidelines and the Code of Conduct (links on the Bayer intranet only). 

In addition, the US Food and Drug Administration (FDA) has additional requirements for apps that:

• are intended to be used as an accessory to a regulated
  medical device
• transform a mobile platform into a regulated medical
  device