ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provides expert tips on how to navigate the process.
By the end of this course, you should be able to:
- Recognize the fundamental requirements from medical device regulation relating to risk management
- Explore the ISO 14971 stepwise approach to risk analysis, evaluation and control
- Recognize the importance of risk management planning and a well maintained risk management file
- Identify risk acceptability criteria and apply solutions for your own organization
- Identify and recognize how to implement risk control measures to evaluate residual risks and reduce all risks to as low as possible
- Recognize the importance of post-production risk management to the overall process
By completing/passing this course, you will attain the certificate Medical Device Certificate
Terms and Conditions Agreement
NSF International is pleased to offer e-learning Courses (the “Course” or “Courses”) for use through this website on the express condition that you agree to and abide by these terms and conditions (the “Agreement”).
“You” or “Your” means the person accessing the Course and, if accessing by or on behalf of a company or organization, “You” or “Your” means such company or organization.
If accessing on behalf of a company or organization, You represent and warrant that You have authority to do so and to bind such company or organization to this Agreement.
NOTICE: READ THE FOLLOWING CAREFULLY BEFORE USING ACCESSING AND PAYING FOR ACCESS TO A COURSE. THE TERMS AND CONDITIONS OF THIS AGREEMENT GOVERN YOUR ACCESS TO AND USE OF THE COURSE. BY ACCESSING, VIEWING, OR USING ANY COURSE YOU EXPRESSLY ACKNOWLEDGE THAT YOU HAVE READ, FULLY UNDERSTAND AND AGREE TO BE BOUND BY ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT.
IF YOU DO NOT WISH TO BE BOUND BY THIS AGREEMENT, THEN DO NOT ACCESS A COURSE AND INSTEAD PLEASE EXIT THIS WEBSITE IMMEDIATELY.
For instructor led courses: We do not accept cancellations. Substitutions will be accepted up to one day prior to the course beginning. We make every effort to avoid changes or cancellations to our courses, NSF reserves the right to withdraw any course. If for any reason NSF cancels a course, all course fees will be returned in full. We cannot however reimburse the cost of any pre-booked travel arrangements and suggest that you might like to consider travel insurance to cover any significant costs incurred.
- Your Computer System and Equipment. You are solely responsible for supplying all equipment, Internet access and bandwidth needed to properly access and use the Course. Before paying for access to any Course, You must confirm the compatibility of your computer system with published computer specification for the applicable Course. NSF shall have no responsibility or liability for Your inability to access the Course due to issues beyond NSF’s control, including but not limited to the speed of Your modem - or other connection devices used, Your use of third party security software or firewall/proxy servers, or the performance levels of Your internet service provider.
- Ownership of the Courses and Your Limited Use. You acknowledge and agree that all Courses, as well as all intellectual property rights and other rights in and to such Courses, are owned exclusively by NSF in their entirety, that such Courses are the intellectual and/or industrial property of NSF, and that such Courses are the preexisting intellectual property of NSF. For avoidance of doubt, nothing in this Agreement conveys any ownership or right in such Courses, except for the non-exclusive, limited time online viewing of the Courses (see Time Limit in Section 3). Notwithstanding anything to the contrary in this Agreement, You shall: (a) at all times maintain the Courses for Your own personal viewing and shall not disclose, publish, distribute, display, give or sell the Courses or portions thereof to or with any third party or any other person within Your company or organization; (b) limit the use of the Courses for Your own educational enhancement; and (c) not copy, print (including screen prints), publish, save (whether in hard copy or electronic form), distribute, give, sell, modify, transmit, or create derivative works without the express written consent of NSF. You agree that NSF has the right to temporarily or permanently limit or bar your access to the Course for any noncompliance with NSF policies and practices as communicated or posted from time-to-time, including but not limited to violation in any form or manner of this Agreement.
- Time Limit of Access for Each Course; Termination. Each Course has a specified time period for access and use (the “Time Limit”). The Time Limit begins when NSF issues Your login details for each Course and ends as stated with respect to each Course. Your right to use and access a Course terminates automatically at the end of the Time Limit. Notwithstanding the foregoing, NSF retains the right to suspend or to terminate Your access and use of a Course for any breach of this Agreement (including non-payment). NSF also retains the right to terminate Your access and use of the Course at any time and for no reason by simply refunding your payment for such Course within sixty (60) days of notice of termination from NSF.
- Payment. Payment shall be made before use of any Course. Fees will be as stated on the applicable website or informational materials about a Course, which fees may change from time-to-time at NSF’s sole discretion. All fees are exclusive of any taxes and duties such as value added tax, sales-and-use tax, import or other duties. You are responsible for paying all taxes and duties at the required rate and in accordance with applicable law. NSF processes payment through a third-party payment provider. NSF shall have no liability for any claims arising out of or in connection with this payment process or the information you provide, including but not limited to the processing or failure to properly process any payment.
- The Platform. You understand and agree that all Courses utilize an online learning platform by LearnUpon Limited (https://www.learnupon.com), which platform includes all documentation, manuals, videos and software in or accessible through this platform (the “Platform”). You agree to comply with the LearnUpon Terms of Services, as updated from time-to-time (see https://www.learnupon.com/terms-of-service/).
- Intellectual Property. In addition to the intellectual property discussed in Section 2 above, all content included or available on or in the Course or this website, including the design, code, text, graphics, interfaces, and the selection and arrangements thereof, is intellectual property or copyright protected materials of NSF, its affiliates, or a third party but it is under no circumstances Your property and You shall have no right, title or interest in any of the foregoing. Any reproduction, retransmission or republication of any or all parts of any part of the Course is expressly prohibited, unless NSF has expressly granted its prior written consent to so reproduce, retransmit or republish the material. The names, trademarks, service marks and logos of NSF or its affiliates appearing on this website or in connection with any Course may not be used in any advertising or publicity, or otherwise to indicate NSF's affiliation with any product or service, without NSF’s prior express written permission. All other rights reserved.
- DISCLAIMERS; COURSE “AS IS”. USE OF THE COURSE IS AT YOUR SOLE RISK. NEITHER NSF NOR ITS AFFILIATES WARRANT THAT USE OF OR ACCESS TO THE COURSE WILL BE UNINTERRUPTED, THAT ANY COURSE IS OR WILL BE FIT FOR ANY PARTICULAR PURPOSE, OR THAT THE CONTENT OF ANY COURSE IS ERROR FREE, ACCURATE, OR UP-TO-DATE. EACH COURSE AND THE PLATFORM ARE PROVIDED “AS IS” AND “AS AVAILABLE”. You expressly acknowledge and agree that due to the rapidly evolving nature of regulatory legislation, content of a Course may become outdated and/or incorrect at any time. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, NSF AND ITS AFFILIATES DISCLAIM ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THAT: (A) USE OR ACCESS TO THE COURSE WILL BE UNINTERRUPTED (B) THE COURSE IS FIT FOR ANY PARTICULAR PURPOSE, (C) THE COURSE IS ERROR FREE, ACCURATE, OR UP-TO-DATE, (D) ANY INFORMATION OR DATA IN THE COURSE CAN BE RELIED UPON BY YOU, OR (E) THE COURSE, THE PLATFORM, AND SERVERS ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.
- LIMITATIONS OF LIABILITY, CLAIMS AND DAMAGES. NSF shall have no liability to You, to your company or organization, or to any third party for consequential, exemplary, special, incidental, or punitive damages even if NSF has been advised of the possibility of such damages. Any claim or cause of action that you may have with respect to your the Course or this Agreement must be commenced within six (6) months after receiving access to any Course. EXCEPT FOR NSF’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, IN NO EVENT SHALL NSF BE LIABLE TO you, to your COMPANY OR organization, or to ANY THIRD PARTY WITH RESPECT TO ANY CLAIM ARISING UNDER THIS agreement or for use of the Course IN AN AMOUNT IN EXCESS OF THE FEES PAID TO NSF for the Course. THE LIMITATIONS of this section APPLY TO ALL CLAIMS IN THE AGGREGATE, INCLUDING, WITHOUT LIMITATION, CLAIMS BASED ON BREACH OF CONTRACT, BREACH OF WARRANTY, PROFESSIONAL NEGLIGENCE, STRICT LIABILITY, MISREPRESENTATIONS, AND OTHER TORTS OR CLAIMS.
- INDEMNIFICATION. You shall be solely responsible for and shall defend, indemnify and hold NSF, its affiliates and their respective employees, agents, officers, directors, and assigns harmless from and against any claims, lawsuits, judgments, losses, liabilities, expenses (including reasonable attorney's fees), costs, damages and awards (collectively “Claims”) including, without limitation, Claims relating to property damage, personal injury, wrongful death or economic loss arising out of or resulting from (a) Your access, use, or misuse of the Course; (b) any violation of Sections 2 OR 6 above; or (c) Your failure to abide by ANY OTHER terms and conditions of this Agreement. This indemnity provision shall survive any and all terminations of this Agreement, THE TIME LIMIT, or use of the Courses.
- Links to Other Websites. A Course may contain links to third party websites. Access to any other website linked to the Course is at the user's own risk and NSF is not responsible for the accuracy or reliability of any information, data, opinions, advice or statements found on those websites, and NSF does not exert any editorial or other control over those other sites. NSF provides these links merely as a convenience to You and the inclusion of such links does not imply an endorsement by NSF of any such third party sites or their content.
- Feedback. To the extent You provide NSF any feedback, ideas, modifications, comments, or suggestions about this website, a Course, this Agreement, or the content of any of the foregoing, then You hereby grant to NSF a nonexclusive, perpetual, irrevocable, worldwide, royalty-free license to use, incorporate, create derivative works or otherwise exploit.
- No Third Party Benefit. This Agreement and each Course is for the benefit of the parties hereto and is not entered into for the benefit of any other person or entity.
- Amendments. NSF reserves the right to amend this Agreement at any time and from time to time. Your continued use of any Course after posting of changes on this website constitutes your acceptance of those changes and NSF has no obligation to inform you of such changes in any other manner.
- Jurisdiction/Choice of Law. Any legal action by any party or any other person relating to this Agreement or the Course shall be brought and maintained exclusively in the United States District Court for the Eastern District of Michigan if it has subject matter jurisdiction, and otherwise in the appropriate District Court or Circuit Court in the State of Michigan as provided in the venue statutes of the State of Michigan. The parties consent to personal jurisdiction and venue in such courts and agree not to invoke the jurisdiction of any other court. This Agreement shall be governed, interpreted and construed in accordance with Michigan law, without regard to its conflicts of law provisions.
- Invalidity. If any of the terms and conditions of this Agreement is adjudged to be invalid, void or unenforceable, the remaining terms and conditions of this Agreement will not be affected thereby. Such invalid provision shall automatically be deemed to be replaced by the lawful provision that most nearly embodies the original intention of the parties as expressed herein, and the remaining terms and conditions of this Agreement will in any event otherwise remain valid and enforceable.
- Entire Agreement. This Agreement, its terms and conditions, as well as such other agreements or documents referenced herein, as each may be amended from time to time, constitute the entire agreement between You and NSF with respect to the subject matter of this Agreement and Your use of the Course, and they supersede all previous communications, representations or agreements, whether oral, written or electronic, between the parties with respect to said subject matter. A printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the terms and conditions of this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
4838-5532-9120, v. 1
Your cart is empty