"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
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).
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
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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.
US and EU
Date, location and venue:
10 October 2018, Copenhagen, Denmark
This course is offered in-house.
Click here for more info and inquiry form.
08.30-16.30 (Registration 08.00-08.30)
7 830 DKK (€ 1 050)
Incl. course material (pdf), lunch and refreshments
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:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.
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.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
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 7 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.