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Compliance Seminars®

Medical Device equipment

Risk Management according to ISO 14971:2019

EN ISO 14971:2019 – understand its importance and relation to MDR and EN ISO 13485:2016.


*MDR - EU Medical Device Regulation

During this one-day course you will get a good understanding of the key requirements that shall be fulfilled to establish and maintain a risk management system in compliance with 14971:2019 and its relation to EU and US Medical Device regulations.

This standard is since December 2019 also on FDAs list of so called
"Recognized Consensus Standards"


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.

Course description:

The course provides practical guidance on how to implement the requirements of EN ISO 14971:2019 in your quality management system. We will discuss how the risk management procedure relates to other processes such as design and development, verification and validation, clinical evaluation, post-market surveillance and usability and how this is reflected in the quality management system. 14971 stipulates that the risk management process shall be reviewed at regular intervals -we will show how this can be integrated into your management review and internal audit program.

During the course you will also get a thorough understanding of EN ISO 14971:2019, as compared to the 2012 version as well its relation to the new Medical Device regulations.

Learning objectives:

  • Know how to interpret and implement the requirements of 14971:2019 in your quality management system
  • Define key input and output of the risk management process
  • Understand the lifecycle approach to risk management
  • Identify the links between ISO 13485:2016, ISO 14971:2019 and the medical device regulations

Course content:

  • Purpose of risk management
  • Planning of the risk management process
  • Risk assessment and risk control
  • Risk review and overall residual risk acceptability
  • Use of post-market surveillance in risk management
  • Implementation of risk management in your quality management system
  • MDR, 14971:2019 and the harmonization process

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.

Need of prior knowledge/experiences:

  • You should have basic knowledge of quality systems
  • You should have some experience from the medical device industry



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Course facts

Course no:
Medical Device



Åse Ek  Simon Sjöhage
Åse Ek and Simon Sjöhage

Date, location and venue:

19 October 2020, Online
Note. New date.

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

1 day

Price (excl. local VAT):
€ 950
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)  
3-5 days prior the course you will receive a download link for the course handouts as a PDF.

Cancellation policy - International public courses  

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.