"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Quality Management

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.

Learning objectives:

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.

Course content:

  • 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).
If you are uncertain about your level of basic GMP knowledge, you can buy and take an online test here »

 

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Do you wish to customize this course to suit your needs?

 If so, running the course in-house is probably the best and most cost effective solution.

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Course facts

Course no:
5123
Industry:
Medical Device

Level:
Intermediate
Region:
US and EU

Language:
English

Instructors:
Tomas Camnell  Helena Dahlin
Tomas Camnell and Helena Dahlin

Date, location and venue:

This course is only offered in-house.
Click here for more info and inquiry form.