This website, domain and the products and services delivered through it are operated by the Foundation for Innovation, Translation and Safety Science, Inc. doing business as the Medical Device Innovation, Safety and Security Consortium (“MDISS”). Throughout the site, the terms “we”, “us” and “our” refer to MDISS. “You”, “Member”, “Your” “User” refers to you, the customer. “The parties” refers to both MDISS and you, the customer. MDISS offers this website, including all information, tools and software delivered as a service (e.g. MDRAP) available from this site to you, the user, conditioned upon your acceptance of all terms, conditions, policies and notices stated here. The MDISS store and e-commerce platform is hosted by Shopify, Inc.; they provide us with the online e-commerce platform that allows us to sell our products and services to you. By visiting our site and/or downloading or purchasing something from us, you engage in our “Service” and agree to be bound by the following terms and conditions (“Terms of Service”, “Terms”), including those additional terms, conditions and policies referenced herein and/or made available via hyperlink. Inclusively, these Terms of Service apply to all users of the site, including without limitation to users who are browsers, shoppers, vendors, customers, merchants, and/ or contributors of content. Please read these Terms of Service carefully before logging in, using our website or participating in any MDISS organized event. By accessing or using any part of the site, you agree to be bound by these Terms of Service. If you do not agree to all the terms and conditions of this agreement, then you may not access the website nor use any MDISS software or services. If these Terms of Service are considered an “offer”, then “acceptance” is expressly limited to these Terms of Service.
Any new features or tools which are added to the current MDISS website, MDRAP portal or any other MDISS offering, service or event shall also be subject to the Terms of Service. You can review the most current version of the Terms of Service at any time on this page. We reserve the right to update, change or replace any part of these Terms of Service by posting updates and/or changes to our website. It is your responsibility to check this page periodically for changes. Your continued use of or access to the website following the posting of any changes constitutes acceptance of those changes. Finally, the headings used in this agreement are included for convenience only and will not limit or otherwise affect these Terms.
By agreeing to these Terms of Service, you represent that you are at least the age of majority in your state or province of residence, or that you are the age of majority in your state or province of residence and you have given us your consent to allow any of your minor dependents to use this site. You may not use our products for any illegal or unauthorized purpose nor may you, in the use of the Service, violate any laws in your jurisdiction (including but not limited to copyright laws). You must not transmit any worms or viruses or any code of a destructive nature. A breach or violation of any of the Terms will result in an immediate termination of all of your Services.
Any reliance on the material on this site is at your own risk. Operating as a moderator of what is essentially a crowdsourced/community website, we cannot guarantee that all information posted by members, device assessors, commentators, visitors or staff members will be totally accurate, complete or current. Thought we strive for these things, we are not responsible for errors, omissions nor delays. The material on this site is provided for general information only and should not be relied upon or used as the sole basis for making medical, patient safety, purchasing or public-health decisions without consulting corroboratory materials and your own expert staff. This site may contain certain historical information. Historical information is necessarily “not current” and is provided for your reference only. We reserve the right to modify the contents of this site at any time, but we have no obligation to update any information on the site. You agree that it is your responsibility to monitor changes to our site.
Prices for our products, membership fees and service pricing are subject to change without notice. We reserve the right to modify or discontinue any of our products or services, including those provided to our members through the MDRAP and MDISS web portals, without notice at any time. We shall not be liable to you or to any third-party for any modification, price change, suspension or discontinuance of any of the Services.
Certain products or services may be available exclusively online through the website. These products or services may have limited quantities and are subject to return or exchange only according to our Return Policy. We have made every effort to portray as accurately as possible the features and benefits of the initiatives and offerings that appear on the store. All descriptions of products or product pricing are subject to change at anytime without notice, at our sole discretion. As our software and services are under continuous “agile” development, we cannot guarantee that said descriptions will precisely match the software or service you receive. We do not warrant that the quality of any products, services, information, or other material purchased or obtained by you will meet your expectations, or that any errors in the Service will be corrected. We reserve the right to limit sales of our products or Services to any particular person, geographic region or jurisdiction, and we reserve the right to limit the quantities of any products or services that we offer to any person, organization or region. If an offer is prohibited in certain geographic regions or organizational contexts, any offer made shall be considered VOID.
Occasionally there may be information on our site or in the Service that contains typographical errors, or inaccuracies or omissions that may relate to any number of product characteristics. We reserve the right to correct any errors, inaccuracies or omissions without prior notice, and to change or update information or even cancel orders if any information in the Service or on any related website is inaccurate at any time of order, at any time, even after you’ve placed your order. We undertake no obligation to update, amend or clarify information in the Service or on any related website, including without limitation, pricing information, except as required by law. No specified update or refresh date applied in the Service or on any related website, should be taken to indicate that all information in the Service or on any related website has been modified or updated.
We reserve the right to refuse any order you place with us. We may, in our sole discretion, limit or cancel quantities purchased per person, per household, per business unit or per order. In the event that we make a change to, or cancel an order, we may attempt to notify you by contacting the e-mail and/or billing address/phone number provided during the placement of the original order. We reserve the right to limit or prohibit orders that, in our sole judgment, appear to be placed by dealers, resellers or distributors that have not previously reached a revenue-sharing agreement with us.
You agree to provide current, complete and accurate purchase and account information for all purchases made at our store. You agree to promptly update your account and other information, including your email address and credit card numbers and expiration dates, so that we can complete your transactions and contact you as needed. Should you wish to cancel and return your membership assets, software and logins, please review our Returns Policy.
We may provide you with access to third-party tools over which we neither monitor nor have any control nor input. You acknowledge and agree that we provide access to such tools ”as is” , without any warranties, representations or conditions of any kind and without any endorsement. We shall have no liability whatsoever arising from, or relating to, your use of optional third-party tools. Any use by you of said optional tools is entirely at your own risk and discretion. You should ensure that you are familiar with and approve of the terms on which those tools are provided by the relevant third-party provider(s).
Certain content, products and services available via our Service may include materials from third-parties. Also, links on this site may direct you to third-party websites that are not affiliated with us. We are not responsible for examining or evaluating these third-party websites, nor are we responsible for the accuracy of content on those sites. We do not warrant and will not have any liability for any third-party materials or websites, or for any other materials, products, or services of third-parties encountered as a direct or indirect result of this Agreement. Likewise, we are not liable for any harm or damages related to the purchase or use of goods, services, resources, content, or any other transactions made in connection with any third-party websites. Please review carefully the third-party’s policies and practices and make sure you understand them before you engage in any transaction with them. Complaints, claims, concerns, or questions regarding third-party products should be directed to the third-party.
If, at our request you send certain specific submissions (for example contest entries) or without a request from us you send creative ideas, suggestions, proposals, plans, or other materials, whether online, by email, by postal mail, or otherwise (collectively, ‘comments’), you agree that we may, at any time, without restriction, edit, copy, publish, distribute, translate and otherwise use in any medium any comments that you forward to us. We are and shall be under no obligation (1) to maintain any comments in confidence; (2) to pay compensation for any comments; or (3) to respond to any comments.
We may, but have no obligation to, monitor, edit or remove content that we determine (in our sole discretion) is unlawful, offensive, threatening, libelous, defamatory, pornographic, obscene, objectionable or in violation of any party’s intellectual property, or these Terms of Service. You agree that your comments will not violate any right of any third-party, including copyright, trademark, privacy, personality or other personal or proprietary right. You further agree that your comments will not contain libelous or otherwise unlawful, abusive or obscene material, or contain any computer virus or other malware that could in any way affect the operation of the Service or any related website. You may not use a false e-mail address, pretend to be someone other than yourself, or otherwise mislead us or third-parties as to the origin of any comments. You are solely responsible for any comments you make and their accuracy. We take no responsibility and assume no liability for any comments posted by you or any third-party.
In addition to other prohibitions as set forth in the Terms of Service, you are prohibited from using the site, its services, members or content: (a) for any unlawful purpose; (b) to solicit others to perform or participate in any unlawful acts; (c) to violate any international, federal, provincial or state regulations, rules, laws, or local ordinances; (d) to infringe upon or violate our intellectual property rights or the intellectual property rights of others; (e) to harass, abuse, insult, harm, defame, slander, disparage, intimidate, or discriminate based on gender, sexual orientation, religion, ethnicity, race, age, national origin, or disability; (f) to submit false or misleading information; (g) to upload or transmit viruses or any other type of malicious code that will or may be used in any way that will affect the functionality or operation of the Service or of any related website, other websites, or the Internet; (h) to collect or track the personal information of others; (i) to spam, phish, pharm, pretext, spider, crawl, or scrape; (j) for any obscene or immoral purpose; or (k) to interfere with or circumvent the security features of the Service or any related website, other websites, or the Internet. We reserve the right to terminate your use of the Service or any related website for violating any of the prohibited uses.
As mentioned above, we do not guarantee, represent or warrant that your use of our service will be uninterrupted, timely, secure or error-free. We do not warrant that the results that may be obtained from the use of the service will be accurate or reliable. You agree that from time to time we may remove the service for indefinite periods of time or cancel the service at any time, without notice to you. You expressly agree that your use of, or inability to use, the service is at your sole risk. The service and all products and services delivered to you through the service are (except as expressly stated by us) provided ‘as is’ and ‘as available’ for your use, without any representation, warranties or conditions of any kind, either express or implied, including all implied warranties or conditions of merchantability, merchantable quality, fitness for a particular purpose, durability, title, and non-infringement.
In no case shall join MDISS, our directors, officers, employees, affiliates, agents, contractors, interns, suppliers, service providers or licensors be liable for any injury, loss, claim, or any direct, indirect, incidental, punitive, special, or consequential damages of any kind, including, without limitation lost profits, lost revenue, lost savings, loss of data, replacement costs, or any similar damages, whether based in contract, tort (including negligence), strict liability or otherwise, arising from your use of any of the service or any products procured using the service, or for any other claim related in any way to your use of the service or any product, including, but not limited to, any errors or omissions in any content, or any loss or damage of any kind incurred as a result of the use of the service or any content (or product) posted, transmitted, or otherwise made available via the service, even if advised of their possibility. Because some states or jurisdictions do not allow the exclusion or the limitation of liability for consequential or incidental damages, in such states or jurisdictions, our liability shall be limited to the maximum extent permitted by law.
Subject to Exhibit B and any other agreement entered into between the parties that separately addresses indemnification, each party is solely responsible for his/her actions and omissions, and Member is solely responsible for the actions and omissions of its Member Representative(s). Member shall indemnify, defend, and hold harmless MDISS, its directors, officers, employees and agents from any third-party claims, liabilities, losses, fines, penalties, charges, judgments, damages or expenses (including reasonable attorneys’ fees) (each, a “Claim”) resulting or arising from Member’s participating in the activities of MDISS including, but not limited to, accessing, using, or distributing information provided by MDISS, Member’s employees or agents or resulting or arising from other information provided by Member hereunder. The indemnification obligations under this section shall survive the termination or expiration of this Agreement with regard to any Claim resulting or arising from actions or omissions that occur prior to the termination or expiration of this Agreement. In the event of any such Claim, MDISS shall promptly provide notice of such Claim to Member. Member shall then have the sole right to control the conduct of the claim or suit and MDISS shall reasonably cooperate in the conduct of such Claim at the expense of Member. In no event, however, may there be a settlement of any such Claim without the written consent of MDISS which consent shall not be unreasonably conditioned, delayed or withheld
In the event that any provision of these Terms of Service is determined to be unlawful, void or unenforceable, such provision shall nonetheless be enforceable to the fullest extent permitted by applicable law, and the unenforceable portion shall be deemed to be severed from these Terms of Service, such determination shall not affect the validity and enforceability of any other remaining provisions. The indemnification obligations under this section shall survive the termination or expiration of this Agreement with regard to any Claim resulting or arising from actions or omissions that occur prior to the termination or expiration of this Agreement. In the event of any such Claim, MDISS shall promptly provide notice of such Claim to Member. Member shall then have the sole right to control the conduct of the claim or suit and MDISS shall reasonably cooperate in the conduct of such Claim at the expense of Member. In no event, however, may there be a settlement of any such Claim without the written consent of MDISS which consent shall not be unreasonably conditioned, delayed or withheld.
The obligations and liabilities of the parties incurred prior to the termination date shall survive the termination of this agreement for all purposes. These Terms of Service are effective unless and until terminated by either you or us. You may terminate these Terms of Service at any time by notifying us that you no longer wish to use our Services, or when you cease using our site. If in our sole judgment you fail, or we suspect that you have failed, to comply with any term or provision of these Terms of Service, we also may terminate this agreement at any time without notice and you will remain liable for all amounts due up to and including the date of termination; and/or accordingly may deny you access to our Services (or any part thereof).
The failure of us to exercise or enforce any right or provision of these Terms of Service shall NOT constitute a waiver of such right or provision. These Terms of Service and any policies or operating rules posted by us on this site or in respect to The Service constitutes the entire agreement and understanding between you and us and govern your use of the Service, superseding any prior or contemporaneous agreements, communications and proposals, whether oral or written, between you and us (including, but not limited to, any prior versions of the Terms of Service). Any ambiguities in the interpretation of these Terms of Service shall not be construed against the drafting party.
These Terms of Service and any separate agreements whereby we provide you services shall be governed by and construed in accordance with the laws of New York.
WHEREAS, MDISS’ mission is to protect public health and well-being by advancing computer risk management practices to ensure wide availability of innovative and safe medical devices through collaborative innovation activities with providers, payers, manufacturers, universities, government agencies, technology companies, individuals, patients, patient advocates and associations; and WHEREAS, Member is interested in being a user of MDISS services and software, and an MDISS member so it can participate in MDISS’ activities; NOW, THEREFORE, for and in consideration of the premises and the mutual covenants contained herein and other good and valuable consideration, the receipt, adequacy and sufficiency of which are hereby acknowledged, the parties hereto covenant and agree as follows:
Member agrees that MDISS is authorized to amend this Agreement subject however to the following provisions and further provided that such amendment does not impose any material obligations upon Member. Member will be given notice in accordance with Section 12 of this Agreement of any changes to this Agreement (except that only electronic mail notice shall be required). In the event that Member objects to any amendment to this Agreement, Member’s sole remedy shall be to terminate this Agreement within 10 business days after Member’s being advised of the amendment. Members will receive a pro rata refund of any fee paid by Member to MDISS that applies to the period after termination for amendments to this Agreement found to be unacceptable to Member. With respect to the subject matter hereof, this Agreement shall supersede any other prior agreement between you and any other MDISS member. MDISS members shall not enter into “side agreements” with other members regarding MDISS technologies, tools, services or practices without first obtaining written permission from MDISS. Except with respect to policies, guidelines, and procedures that may be adopted by MDISS, you and every Member agrees to comply with all applicable laws and regulations while participating in MDISS.
MDISS offers several tiers of membership; each tier is priced higher or lower in accordance with the number of benefits the Member receives. What follows is a list of all possible membership tiers. Match the membership tier you purchased to the chart here to determine the benefits to which you are entitled. All of the following lists are an enumeration of suggested partnership activities, and they do not represent a commitment to provide programs or services. MDISS programs and benefits are subject to change, and global standards initiatives are seasonal. That means some programs or benefits might not be active during the specific period of your membership. If a listed benefit is unavailable for any reason, MDISS will make commercially reasonable efforts to provide replacement benefits of similar value.
B1. Member shall have the right to access MDRAP in accordance with MDISS terms and conditions for so long as Member’s membership is in good standing.
B2. Use of MDRAP is wholly voluntary. In recognition of the fact that MDISS is providing Member with access to MDRAP without charge, to the maximum extent permitted by applicable law, MDISS will not be liable to Member for any personal injury, property or other damage, of any nature whatsoever, whether special, indirect, consequential, or compensatory (including, but not limited to business interruption, loss of use or loss of profits), directly or indirectly resulting from the publication, use of, or reliance upon MDRAP, even if advised of the possibility of such damages or if such possibility was reasonably foreseeable.
B3. Member grants MDISS the right to use data entered into MDRAP by Member in furtherance of MDISS’ public health mission. MDISS will anonymize and aggregate any information used, unless Member provides written consent otherwise. Notwithstanding the foregoing, MDISS will not use any data designated as “Protected Health information” under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”).
B4. Member recognizes that MDRAP was developed through a consensus process which brings together volunteers representing varied viewpoints and interests to achieve a final product. While MDISS administers the process, and establishes rules to promote fairness in consensus development, MDISS does not independently evaluate, test, or verify the accuracy of any of the information or the soundness of any judgments contained in MDRAP. Any information provided by MDRAP to MDISS is provided on an “as is” basis without any warranty of any kind, expressed or implied.
B5. The existence of MDRAP does not imply that there are no other ways to perform a risk assessment of medical devices. Furthermore, the viewpoint expressed at the time MDRAP was approved and issued is subject to change brought about through developments in the state of the art and comments received from users of MDRAP.
B6. In publishing and making MDRAP available, MDISS is not rendering professional or other services for, or on behalf of, any person or entity, nor is MDISS undertaking to perform any duty owed by any other person or entity to another. Any person utilizing MDRAP, should rely upon his or her own independent judgment in the exercise of reasonable care in any given circumstances or, as appropriate, seek the advice of a competent professional in determining the appropriateness of MDRAP’s assessments.
B7. MDISS DISCLAIMS AND EXCLUDES ALL REPRESENTATIONS, WARRANTIES, AND CONDITIONS, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING BUT NOT LIMITED TO REPRESENTATIONS, WARRANTIES, OR CONDITIONS OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY OF DATA, QUALITY, SYSTEM INTEGRATION, SUITABILITY, OR THE ABSENCE OF ANY DEFECTS THEREIN, AND WARRANTIES ARISING FROM COURSE OF DEALING, COURSE OF PERFORMANCE AND USAGE OF TRADE. MDISS DOES NOT WARRANT THAT ACCESS TO, OR OPERATION OF, MDRAP WILL BE UNINTERRUPTED, SECURE OR ERROR-FREE, THAT ERRORS WILL BE CORRECTED, OR THAT MDRAP WILL SATISFY MEMBER’S OR ANY THIRD PARTY’S REQUIREMENTS. MDISS DOES NOT WARRANT OR REPRESENT THE ACCURACY OR CONTENT OF THE MATERIAL CONTAINED IN MDRAP. MDRAP IS SUPPLIED “AS IS.”
B8. CONFIDENTIALITY. MDISS will maintain as confidential all Confidential Information (as defined below) of Member or its Members obtained under or in connection with this Agreement and will not divulge such information to any person (except to its own trustees, officers, employees and agents and then only to those such persons who need to know same in connection with performing under this Agreement) without Member’s prior written consent. This clause will not extend to information which was rightfully in the possession of MDISS prior to the commencement of the negotiations that led to this Agreement, which was already in the public domain or becomes so at a future date (otherwise than as a result of a breach of this clause or any other confidentiality agreement signed by MDISS), or which was independently developed by MDISS without use of Member’s Confidential Information. MDISS will ensure that its directors, officers, employees and agents are aware of and comply with the requirements of this clause. If requested, MDISS or its directors, officers, employees and agents will sign a confidentiality agreement in a reasonable form specified and provided by Member. These obligations of confidentiality will survive the termination or expiration of this Agreement. Member will maintain as confidential all Confidential Information (as defined below) of MDISS obtained under or in connection with this Agreement, and will not divulge such information to any person (except to its own employees or agents and then only to those employees or agents who need to know same in connection with performing under this Agreement) without MDISS’s prior written consent. This clause will not extend to information which was rightfully in the possession of Member prior to the commencement of the negotiations that led to this Agreement, which was already in the public domain or becomes so at a future date (otherwise than as a result of a breach of this clause or any other confidentiality agreement signed by Member), or which was independently developed by Member without use of MDISS’s Confidential Information. Member will ensure that its employees or agents are aware of and comply with the requirements of this clause. If requested, Member or its employees or agents will sign a confidentiality agreement in a reasonable form specified and provided by MDISS. These obligations of confidentiality will survive the termination or expiration of this Agreement. In each case, the term “Confidential Information” shall mean any and all technical and non-technical information disclosed by a Party which may include without limitation: (a) patent and patent applications, (b) trade secrets, and (c) proprietary and confidential information, ideas, samples, media, techniques, sketches, drawings, works of authorship, models, inventions, know-how, processes, apparatuses, equipment, algorithms, software programs, software source documents, and formulae related to the current, future, and proposed products and services of each of the Party, such as information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, investors, employees, business and contractual relationships, business forecasts, sales and merchandising, and marketing plans.