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Compliance Seminars®

Quality Management

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.

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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Course facts

Course no:
Medical Device

US and EU

Åse Ek
Åse Ek
Symbioteq Kvalitet AB

Date, location and venue:

11 December 2020, Copenhagen
Industriens hus
H.C. Andersens Blvd. 18    

Register by 30 October - Save 2 250 DKK (€ 300)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Kødbyen (800m)
» Scandic Copenhagen (800m)

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

1 day
09.00-17.00 (Registration 08.30-09.00)

Price (excl. local VAT):
Register by 30 October and save 750 DKK (€ 100)
Until 30 Oct: 7 080 DKK (€ 950)
From 31: 7 830 DKK (€ 1 050)
incl. course material (pdf)

Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

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 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.

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.