
Post-market surveillance
Is a set of activities conducted by manufacturers, to collect and evaluate
experience gained from medical devices that have been placed on the market, and to identify the need to take any action.The purpose of post-market surveillance is to protect individual health and public health through continued surveillance of IVDs once they are placed on the market by reducing any risks
Vigilance
The WHO Global Model Regulatory Framework for Medical Devices also includes the activities of the national regulatory authorities (NRAs) acting in response to reports of adverse events received, so-called vigilance OR investigation of adverse events to determine root causes and the consequent corrective and preventive action.
Market surveillance
The activities carried out and measures taken by competent authorities (regulatory authorities) to check and ensure that devices comply with the requirements set out in the relevant legislation and do not endanger health, safety or any other aspect of public interest protection
ISO/TR 20416:2020
Medical devices
Post-market surveillance for manufacturers
Basic principles of post-market surveillance
Rationale for PMS
Pre Market Vs Post Market Evaluation
Pre Market
Pre-market evaluation of product quality, safety and performance is conducted by manufacturers of
medical devices prior to entry on to the market. Decisions with regard to reducing risks and residual
risk acceptability are made based on risk management principles. However, issues might arise after the medical device is placed on the market.
List of Queries-
What is POST MARKET SURVEILLANCE
How to conduct POST MARKET SURVEILLANCE
POST MARKET SURVEILLANCE kyaहै
Post Market Surveillance kaise karte hai
PMS Kya hota hai
PMS for medical devices
PMS for IVD
PMS for Pharma
What is Post Marketing Surveillance for Medical Devices? (MDR 2017/745)
How to do PMS for Indian Market
India PMS for Medical Device
iso 13485 medical devices
iso 13485 medical devices in hindi
medical device manufacturers
in vitro diagnostics
IVD MANUFACTURING
IVD
Manufacturing
QMS
MDR2017
production
diagnostics
Audit
medicaldevice
QMS
IVDMANUFACTURING
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