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Medical Device Postmarket Surveillance
Key requirements in ISO 13485, MDR /IVDR*, and QSReg **
* MDR - EU Medical Device Regulation, IVDR – EU InVitro Diagnostic device Regulation
** QSReg - US Medical Device Quality System Regulation 21 CFR 820
During this one day course, you will get a good insight and understanding of the key requirements that shall be fulfilled to establish and maintain a postmarket surveillance system in compliance with EU and US Medical Device regulations.
The course provides practical guidance on how to implement the requirements on Postmarket Surveillance (PMS) in your quality management system and establish a system for proactive and reactive data collection and subsequent data/trend analysis, to identify potential and existing nonconformities. This course outlines the postmarket surveillance process; from the planning phase to implementation and analysis.
To get a thorough understanding of the requirements on Postmarket Surveillance (PMS) in MDR and IVDR as well as FDA’s requirements on PMS. Know how to establish and assess the postmarket aspects of your process for measurement, analysis and improvement, according to ISO 13485:2016. Understand the link between risk management, postmarket surveillance and clinical evaluation; especially postmarket clinical follow-up. Learn about requirements on different stakeholders for regulatory reporting as defined in EU and US regulations.
- How to create and update your Postmarket surveillance plan.
- Analysis and evaluation; trending.
- Important elements of your quality management system to ensure compliance to PMS regulations.
- Periodic safety update reports – new PMS reporting requirements under MDR.
- Relation between PMS, risk management and clinical evaluation.
Who should attend:
The course is suitable for persons working with quality and/or regulatory for medical devices who is involved in parts of, or responsible for the postmarket surveillance and vigilance reporting for medical devices.
Need of prior knowledge/experiences:
- You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company's internal quality assurance programs.
- You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).
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