What is PMS documentation translation?

PMS documentation translation covers post-market surveillance documents such as PMS plans, PMS reports, summaries, trend analyses and supporting evidence used to monitor a medical device's safety and performance after market launch. Under the MDR, PMS is an ongoing activity feeding CER updates, vigilance flows and benefit-risk reassessment. Multilingual content must accurately reflect approved source material with controlled medical device terminology and version alignment to CERs, SSCPs and related documentation. AbroadLink supports PMS documentation translation with qualified medical linguists, terminology control and risk-based workflow selection appropriate to the content.