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This Technical Information Report (TIR) provides a process and guidance on performing a radio-frequency (RF) wireless coexistence evaluation of a medical device as part of an overall medical device risk management approach. The process includes pre-testing activities to gather information needed to determine the tier at which to perform testing, the testing and report, and post-test analysis. The TIR also provides sample reports and additional information to aid in documenting the medical device wireless coexistence evaluation and integration into risk assessment and management.
Product Details
- Published:
- 04/28/2017
- ISBN(s):
- 9781570206566
- Number of Pages:
- 61
- File Size:
- 1 file , 460 KB
