Episode 2 : Infusing Risk-Benefit Analysis into Clinical Evaluation Reports
Released Tuesday, 3rd March 2015
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Episode 2 : Infusing Risk-Benefit Analysis into Clinical Evaluation Reports
Episode 2 : Infusing Risk-Benefit Analysis into Clinical Evaluation Reports
Tuesday, 3rd March 2015
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In this episode, the Frestedt Incorporated team discusses their recent experience with writing 14 Clinical Evaluation Reports (CERs), including the purpose and scope of these reports and some tips to address common pitfalls they observed during CER writing. Links to resources in this episode: Med Dev 2.7.1 http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf EN ISO 14971:2012 (link to purchase; […]
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