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Compliance Seminars®

Quality Management

Now online - 4 June

Medical Device Postmarket Surveillance - PMS

- How to maintain an efficient PMS system in compliance with 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.

Disposition of online education:

The theoretical sections are presented online. After each section, there are interactive exercises and tasks to be solved individually. The training ends with a joint summary.
For the best results, there are breaks for reflection and for the participants to have the opportunity to ask questions.

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 »

 

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
Watch this short video to learn more about what Gate2GMP® offers »

 

Bring this course in-house?

Are you a group in need of the same training?
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.

Make an enquiry

 

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Course facts

Course no:
5123
Industry:
Medical Device

Level:
Intermediate
Region:
US and EU

Language:
English
Instructor:
Åse Ek
Åse Ek
Symbioteq Kvalitet AB

Date, location and venue:

4 June 2020, On-line (Live)

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


Time:
1 day
08.30-15.30 (Lunch break 12.00-13.00)


Price (excl. local VAT):
850 Euro
incl. course material (pdf)


Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 1MBit/s) and audio capabilities (speakers or headphones).
We are using the easy to use application "GoToWebinar".
See more about how to join a session and the system requirements here »

Instructions will be attached to your order confirmation.

Cancellation policy - Online courses:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.

Cancellations received less than 7 days before the course will be charged 50% of the course fee.
Cancellations received less than 24 hours before the course or in case of failure to cancel, the course fee will be charged in full.