"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
EN ISO14971:2019 - Risk management
– understand its importance and relation to MDR and EN ISO13485:2016
On-line live webinar
New Regulatory Environment
New technology enables new effective diagnostic and therapeutic methods as well as new challenges in controlling new hazards. Manufacturers of medical devices are expected to comply with a more demanding regulatory environment as effectively reducing risks, as low as possible for patients and bystanders. It is essential to establish processes that are aligned with the state of the art related to technologies used as well as an effective state of the art risk management process.
This webinar provides guidance on how to implement the requirements of EN ISO 14971:2019 in your quality management system and how to deal with critical elements of the quality management system.
During the course you will also get a thorough understanding of the major changes in the newly updated EN ISO 14971:2019, as compared to the 2012 version as well its relation to the new Medical Device regulations (MDR/IVDR)
Participants will get to know the key elements of a risk management system in line with the requirements in EN ISO 14971:2019 and MDR. Completion of this course will give you the knowledge needed to assess and update your current risk management process
- Risk management requirements in MDR
- Requirements in EN ISO 13485:2016
- EN ISO 14971:2019, updated risk management process and new definitions
- Risk management for a medical device, different methods
- Risk acceptance criteria’s
- Risk estimation, risk evaluation and risk control
- Documentation requirements
Who should attend:
The course is suitable for persons working with R&D, production, process development or QA who is involved in, or responsible for the operation or audit of a Risk Management System for medical devices who need to know the changes introduced in ISO14971:2019 (EN ISO 14971:2019).
Need of prior knowledge/experiences
- You should have basic knowledge of quality systems
- You should have some experience from the medical device industry
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 »
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If so, running the course in-house is probably the best and most cost effective solution.
Symbioteq Kvalitet AB
15 April 2020 - Online
13.30 - 15.30 CET (Central European Time)
Price (excl. local VAT):
250 Euro for the first participant.
115 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contact us for an offer.
You need access to a computer, tablet or mobile phone with internet connection (preferably min 700kB/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 for webinars:
Cancellations received less than 7 days before the webinar will be charged 50% of the course fee.
Cancellations received less than 24h before the webinar will be charged 100% of the course fee.
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.
In case of failure to cancel before the course, the course fee will be charged in full.
Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.