Process Flow of Medical Writing Experts

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Medical Writing Experts Process Flow Reclassification “Decide route regarding conformity evaluation” Legacy product market access “Ensuring products are CE marked” Single Use Device Reprocessing “Reprocessing allowed only under national law” Technical Documentation “Stringent technical documentation” Clinical Evaluation “Warrants entensive clincal evidence” Post Market Surveillance and vigilance “Assimilate post market clinical data” Mandatory insurance for Product Liability “Ensuring substantial coverage is provided for liability” Transparency “Closely monitor EUDAMED” Labeling “More prescriptive labeling requirement” Unique Device Identification “Mandatory tracing of all medical devices” About Medical Writing Experts (MedEx) Medical Writing Experts(MedEx) is a leading global provider of scientific, clinical and medical communication services to pharmaceutical, biotech, device companies and researchers, scholars, academic societies and publishers. The mission of Medical Writing Experts is to translate clinical research and enable sustainable growth through effective medical communication. We have more than 100,000 individuals working across the globe and expertise across over 300 scientific discipline. Quickly connect us: UK: +44-1143520021 US/Canada: +1-972-502-9262 India: +91-8754446690

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Medical Writing Experts - Process Flow For Enquires or Quote please contact infomedicalwritingexperts.com www.medicalwritingexperts.com

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Reclassification “Decide route regarding conformity evaluation” Legacy product market access “Ensuring products are CE marked” Single Use Device Reprocessing “Reprocessing allowed only under national law” Technical Documentation “Stringent technical documentation” Clinical Evaluation “Warrants entensive clincal evidence” Post Market Surveillance and vigilance “Assimilate post market clinical data” Mandatory insurance for Product Liability “Ensuring substantial coverage is provided for liability” Transparency “Closely monitor EUDAMED” Labeling “More prescriptive labeling requirement” Unique Device Identification “Mandatory tracing of all medical devices” For Enquires or Quote please contact infomedicalwritingexperts.com www.medicalwritingexperts.com

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About Medical Writing Experts MedEx Medical Writing ExpertsMedEx is a leading global provider of scientific clinical and medical communication services to pharmaceutical biotech device companies and researchers scholars academic societies and publishers. The mission of Medical Writing Experts is to translate clinical research and enable sustainable growth through effective medical communication. We have more than 100000 individuals working across the globe and expertise across over 300 scientific discipline. Quickly connect us: UK: +44-1143520021 US/Canada: +1-972-502-9262 India: +91-8754446690 For Enquires or Quote please contact infomedicalwritingexperts.com www.medicalwritingexperts.com

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