Medical Device University (MDU) is a digital platform on which users can learn about medical device approval and guidance to market readiness in the USA and Europe (collectively hereinafter the “Service” or “Services”).
Our Services include training videos and templates for the user to learn everything they need to know about medical device regulation. The Services are intended to provide a full 820 CFR compliant quality management system and the technical documentation for medical devices.
The Service only delivers resources, and the templates needed to fill out and adapted to the specific requirements of the medical device the user intends to document.
We allow you to access our various Services in exchange for a one-time or recurring fee (collectively the "Subscription").
By using the Service, you signify your acceptance of the terms of the Agreement. Please read the terms of the Agreement carefully. If you do not understand the terms, or do not accept any part of the Agreement, then you may not use the Service.
Each time you place an order for a Subscription (including when you order individual subscriptions or items of content), you enter into a separate contract for services on the terms of the Agreement, as may be amended from time to time. When you make a payment for Subscription, you signify that you wish to enter into a binding contract for the provision of the applicable Services
We accept payment via the current payment method(s) indicated prior to purchase, which we make available to you from time to time. You must have a valid accepted form of payment on file in order to purchase or renew a Subscription. You agree to abide by any relevant terms of the Agreement, as defined herein. Prices for any Subscription may change at any time, and we do not provide price protection or refunds in the event of a price reduction or promotional offering. You agree to pay for any Subscription that you order. We will charge your credit card or other form of payment for the price listed on the relevant Subscription, along with any additional amounts relating to applicable taxes, bank fees and currency fluctuations. If you purchase any automatically renewing Subscriptions, you agree that we will charge the payment method on file on the first day of each billing period for the relevant Subscription, and if the payment method on file becomes invalid due to an expired credit card or other similar reason and we are unable to charge you on the next billing period, We reserve the right to immediately revoke your access to any Service you have ordered until you update your payment method and payment for the Subscription is recieved. If you fail to update your payment method within a reasonable amount of time, we may cancel your Subscription.
If we are required to collect or pay any taxes in connection with your purchase of a Subscription, such taxes will be charged to you at the time of each payment transaction. Additionally, if required by law, you are responsible for reporting and paying certain taxes in connection with your purchase and use of a Subscription. Such taxes may include duties, customs fees, or other taxes (other than income tax), along with any related penalties or interest, as applicable to your purchase or country of purchase.
You can cancel your purchase and receive a refund as long as you have not commenced using the relevant Services ordered and you make your request no later than 7 working days after your order is completed. Requests for refunds must be directed to us at: firstname.lastname@example.org. We reserve the right to approve or deny refund requests after 7 working days at our sole discretion. In the event a refund is issued after 7 days for any Subscription, you may be issued a partial refund that is pro-rated for the remaining time left on the Subscription. If you receive a refund for any reason, we reserve the right to terminate your access to the relevant Services purchased.
If you purchase a Subscription that automatically renews, you may cancel the Subscription any time before the end of the current billing period and the cancellation will take effect on the next billing period. You will retain access to the Services from the time you cancel until the start of the next billing period, and will not receive a refund or credit for any remaining days in your current billing period.
Device and Usage Requirements. Certain types of Subscription may require you to use a device that meets certain system and compatibility requirements for such Services, which may change from time to time. Geographic Restrictions. The Subscription, and certain content available within the Subscription, are currently available only in some countries. You agree that you will not present any false, inaccurate or misleading information in an effort to misrepresent yourself as a resident of a supported country, and you will not attempt to circumvent any restrictions on access to or availability of the Subscription or content available within the Subscription.
The Subscription must be only for commercial purposes unless otherwise agreed to in writing. You agree not to use any Paid Service, in whole or in part in connection with any public presentation even if no fee is charged (except where such use would not constitute a copyright infringement). You are receiving a non-exclusive license to access the Services and all rights, title and interest in the Services (including any content offered through the Subscription) not expressly granted to you in these terms are reserved by JOHNER and its licensors, if any. If JOHNER reasonably determines that you violated any of the terms and conditions of the terms of the Agreement, your rights under this Section 4 will immediately terminate and JOHNER may terminate your access to the Services and/or your account without notice and without refund to you.
When you use the Service, you may not (or attempt to):
Changes or Discontinuation. JOHNER reserves the right to change the availability of Services. In addition, we reserve the right to modify, suspend, or discontinue any Service with or without notice to you and we will not be liable to you or any third party for any such modifications, suspension, or termination. However, this will not affect your ability to request a refund as described above.
Removal or Unavailability of Content. In certain cases, content available within a Subscription may become unavailable due to restrictions from our partners who license us such content or other legal or policy reasons. JOHNER will have no liability to you for any such unavailability.
Changes to the Agreement. We may also change these the terms of the Agreement from time to time so we encourage you to periodically review the most up-to-date versions. By completing the purchase or renewal of a Subscription, you signify your agreement to the new terms, and further, that they will apply to your Subscription and use of the Service as a whole (including any Subscriptions you have purchased in the past) and all subsequent Subscription purchases or renewals (until the terms may be amended again). If you refuse to accept the updated terms then you may not buy any additional Subscription, or renew an existing Subscription, and the latest version of the terms that you accepted will continue to apply to your use of previous Subscription.
You acknowledge and agree that certain content available in the Subscription may be considered offensive to some people and that such content may not be labeled as such. Additionally, certain descriptions of Services or content available in the Subscription are not guaranteed to be accurate. You agree to use the Services at your own risk and, subject to applicable laws, JOHNER will have no liability to you for any content that you find offensive or is otherwise inaccurate.
The Subscription and Services are being provided by JOHNER INSTITUTE NORTH AMERICA INC., a Delaware Corporation, reachable via mail at:
JOHNER INSTITUTE NORTH AMERICA INC.
Attn: Online Subscription Agreement
1738 Elton Rd #138
Silver Spring, MD 20903
via email online form at: email@example.com. Complaints and/or feedback about your experience may be sent to the address above or provided online as described above.
You agree that you are solely responsible for (and that JOHNER has no responsibility to you for) your use of any Service, your reliance on any Service or content, any breach of your obligations under the terms of the Agreement, and for the consequences (including loss or damage of any kind which Silver Spring may suffer) of any such breach.
You acknowledge and agree that you are responsible for paying all fees in a timely manner and for providing us with a valid credit card or other acceptable form of payment. IN ADDITION, YOU ACKNOWLEDGE THAT YOUR ONLINE ACCEPTANCES CONSTITUTE A BINDING AGREEMENT BETWEEN YOU AND JOHNER AND SIGNIFY YOUR INTENT TO BE BOUND TO SUCH ONLINE ACCEPTANCES.
SUBJECT TO APPLICABLE LAWS, IN NO EVENT WILL JOHNER OR ITS AFFILIATES' AGGREGATE LIABILITY FOR ANY AND ALL CAUSES OF ACTION BROUGHT BY YOU OR YOUR AGENTS ARISING FROM OR RELATED TO THE SERVICES EXCEED THE PAYMENTS ACTUALLY RECEIVED AND RETAINED BY JOHNER FROM YOU FOR THE SUBSCRIPTION.
Unless not permitted by applicable law, you acknowledge and agree that that the terms of the Agreement, your transaction for the Subscription, and your relationship with JOHNER under the terms of the Agreement shall be governed by the laws of the State of Delaware, U.S.A., without respect to its conflict of laws principles, and any claim or dispute that arises in whole or in part from your use of the Services and the Subscription will be decided exclusively by a court of competent jurisdiction located in County of JOHNER’s principal place of businesses.
You acknowledge and agree that your Subscription payment(s) for the Service is with JOHNER INSTITUTE NORTH AMERICA INC.
OTHER THAN AS EXPRESSLY STATED IN THIS AGREEMENT OR AS REQUIRED BY LAW, THE SERVICE IS PROVIDED “AS IS” AND JOHNER DOES NOT MAKE ANY SPECIFIC COMMITMENTS OR WARRANTIES ABOUT THE SUBSCRIPTION, SERVICES. FOR EXAMPLE, WE DON’T MAKE ANY WARRANTIES ABOUT: (A) THE CONTENT PROVIDED THROUGH THE SERVICE; (B) THE SPECIFIC FEATURES OF THE SERVICE, OR ITS ACCURACY, RELIABILITY, AVAILABILITY, OR ABILITY TO MEET YOUR NEEDS; OR (C) THAT ANY SERVICE OR CONTENT GUARANTEES ANY RESULT OR OUTCOME.
Limitation of Liability
EXCEPT AS REQUIRED BY APPLICABLE LAW, JOHNER, ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES AND AGENTS WILL NOT BE RESPONSIBLE FOR ANY LOSS OF PROFITS, REVENUES, BUSINESS OPPORTUNITIES, GOODWILL, OR ANTICIPATED SAVINGS; LOSS OR CORRUPTION OF DATA; INDIRECT OR CONSEQUENTIAL LOSS; PUNITIVE DAMAGES CAUSED BY:
THIS PROVISION APPLIES TO ANY CLAIM, REGARDLESS OF WHETHER THE CLAIM ASSERTED IS BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY.
To the extent permitted by applicable law, you agree to defend, indemnify and hold harmless JOHNER, its Affiliates, officers, directors, employees and agents, from and against any and all claims, damages, obligations, losses, liabilities, costs or debt, and expenses (including but not limited to attorney's fees) arising from: (i) your use of and access to the Services; (ii) your violation of any term of the Agreement; (iii) your violation of any third party right, including without limitation any copyright, property, or privacy right; or (iv) any claim that you caused damage to a third party. This defense and indemnification obligation will survive the Agreement, your use of the Service and your Subscription.
Modifying this Agreement
We may modify this Agreement, for example, to reflect changes to our Services or for legal, regulatory, or security reasons. JOHNER will provide reasonable advance notice of any material modifications to the Agreement and the opportunity to review the same, except that modifications addressing newly available features of the Services or modifications made for legal reasons may be effective immediately without notice. Modifications to the Agreement will only apply going forward. If you do not agree to the modified terms, you should discontinue your use of the Services and cancel the renewal of your Subscription.
If it turns out that a particular term of the Agreement is not enforceable for any reason, this will not affect any other terms of the Agreement.
If you fail to comply with the Agreement and we do not take immediate action, this does not mean that we are waiving any rights that we may have (such as the right to take action in the future).
Limitation on Legal Action
TO THE EXTENT PERMITTED BY LAW, YOU AND JOHNER AGREE THAT ANY CAUSE OF ACTION ARISING OUT OF OR RELATED TO THE SERVICES MUST COMMENCE WITHIN ONE (1) YEAR AFTER THE CAUSE OF ACTION ACCRUES. OTHERWISE, SUCH CAUSE OF ACTION IS PERMANENTLY BARRED.