We plan on using SYSBIOS in a class 3 medical device
I found this below BLURB in a pdf for TI-RTOS which is based on SYSBIOS
Is this agreement required for SYSBIOS as well
Buyer acknowledges and agrees that it is solely responsible for compliance with all legal, regulatory and safety-related requirements
concerning its products, and any use of TI components in its applications, notwithstanding any applications-related information or support
that may be provided by TI. Buyer represents and agrees that it has all the necessary expertise to create and implement safeguards which
anticipate dangerous consequences of failures, monitor failures and their consequences, lessen the likelihood of failures that might cause
harm and take appropriate remedial actions. Buyer will fully indemnify TI and its representatives against any damages arising out of the use
of any TI components in safety-critical applications.
In some cases, TI components may be promoted specifically to facilitate safety-related applications. With such components, TI’s goal is to
help enable customers to design and create their own end-product solutions that meet applicable functional safety standards and
requirements. Nonetheless, such components are subject to these terms.
No TI components are authorized for use in FDA Class III (or similar life-critical medical equipment) unless authorized officers of the parties
have executed a special agreement specifically governing such use.