Post-Market Surveillance and Post-Market Clinical Follow-Up of Medical Devices

Medical Device

2/20/2020

• Requirements of PMS/PMCF acc. to the MDR
• PMS/PMCF throughout the lifecycle of a medical device
• Trend reporting in PMS
• How to monitor undesirable side effects and match them with the Risk Management File
• How to monitor misuse of device
• Vigilance as part of PMS
• Approval of PMCF studies
• Market surveillance

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