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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.

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Pre-Cert Update: US FDA lays out next steps for SaMD certification program

Russian Ministry of Health articulates role of SaMD in medical device regulation

Applying Human Factors Engineering in Medical Device Development – Regulatory Expectations and Trends

Root Cause Analysis of Use Errors and Assessment of Residual Risk

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