Comprehensive regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way the U.S. is utilizing MDSAP.
By the end of this course, you should:
- Understand the legal and regulatory framework for developing, marketing, and distributing medical devices.
- Understand the Medical Device Single Audit Program (MDSAP) and its function in the United States.
- Identify the premarket regulations and pathways to market for medical devices.
- Distinguish how the Food & Drug Administration (FDA) classifies medical devices.
- Recognize when clinical data is required and the basic requirements for conducting clinical investigations.
- Determine the application of postmarket regulations, including quality systems (QSM) and adverse event reporting.
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”).
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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.
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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.
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- 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.
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- 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.
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