STRIDE BP Review of an Equivalent/Identical Device
EQUIVALENT Device Application
No differences between devices in elements affecting the BP measurement accuracy (see Technical information below), but differences in elements not affecting BP measurement accuracy.
IDENTICAL Device Application*
No differences between devices.
* If your new device is IDENTICAL to a device which currently appears at STRIDE BP website and is also EQUIVALENT to another device, again appearing at STRIDE BP website, please submit only data for the two IDENTICAL devices.
For a new device to be reviewed and potentially approved, the application must provide the following information for both reference and equivalent/identical device:
- Technical information
- Signal sensor (Transducer) and processing
- Blood pressure estimation algorithm
- Inflation and deflation system
- Cuff size and shape
- Devices’ photos
- Cuffs’ photos
- Links to manufacturer’s dedicated device pages
A payment of € 600 (+VAT if applicable) to STRIDE BP (bank account details shown below) is necessary for reviewing this application irrespective of approval or rejection of the Equivalence/Identical Device. This means that you must provide the transaction number of the payment.
STRIDE BP bank account details:
|Leof. Kifisias 218, Chalandri 15231, Athens, Greece
These Terms of Service (“Terms”) apply to the services (as set out below) provided by STRIDE BP, a non-profit organization with an address at University of Athens, School of Medicine, Third Department of Medicine, Hypertension Center STRIDE-7, Sotiria Hospital, 152 Mesogion Avenue, Athens 11527, Greece, VAT number 996826308 (hereinafter “STRIDE BP” or “we”) when you complete and submit the online application form “STRIDE BP Review of an Equivalent/Identical Device” located at https://www.stridebp.org/stride-bp-review-of-an-equivalent-identical-device/ (“Form”). By submission of this online form, you indicate acceptance of these Terms and confirm your intention to be legally bound by them, beginning on the date when the form is submitted. The Terms together with the Form submitted constitute our agreement (“Agreement”).
Using the Form, you will submit validation data for a blood pressure device manufactured by you, which is substantially the same as a device also manufactured by you which has already been approved by STRIDE BP and is listed on our website (https://www.stridebp.org/) (“Site”). We will review this validation data and may grant you equivalence/identical status in accordance with the criteria set out here https://stridebp.org/about-us/principles-for-device-listing as updated from time to time and as advised by the STRIDE BP Scientific Advisory Board. If equivalence/identical status is granted, we will publish the data and the result of our review on our Site. Your application may be rejected if the criteria for the equivalence/identical status are not met (“Services”).
Intellectual Property Rights
Certain names, logos, and other materials displayed on our Site may constitute trademarks, trade names, service marks or logos (“Marks”) of STRIDE BP or other entities. You are not authorised to use any such Marks. More specifically, you are not authorised to use any Marks by organisations affiliated with STRIDE BP, including the European Society of Hypertension, the International Society of Hypertension, the World Hypertension League, the Chinese Hypertension League, and others. Ownership of all such Marks and the goodwill associated therewith remains with STRIDE BP or other entities.
STRIDE BP reserves the right to modify, temporarily or permanently, its Site or any portion thereof without notice, if this does not affect the Services. STRIDE BP will not be liable to the Client, or any third party, should STRIDE BP exercise that right.
Term and Termination
The Term of the Agreement begins upon submission of the Form and receipt of payment by STRIDE BP. The payment is a one-time transaction and is due and payable before the Services commence. A final decision on the approval or rejection of the submitted device will be announced to you within 6 weeks from the date of data submission.
The Agreement ends on completion of Services. The Agreement cannot be terminated once the Services have commenced nor can refunds be issued if you do not wish to receive the Services or are not satisfied with the result of our review.
Limitation of liability
You will not hold STRIDE BP liable for any damages of any kind from your use of our Services and notwithstanding anything to the contrary; in no case shall our liability exceed the fees you pay STRIDE BP for the data submission on the “STRIDE BP Review of an Equivalent/Identical Device” online form.
You agree to indemnify and hold harmless STRIDE BP, its licensors, and suppliers, and the officers, advisors, employees, and agents of each, from and against any and all third-party claims, liabilities, damages, losses, costs, expenses and fees (including reasonable legal fees and court costs) that such parties may incur as a result of or arising from or out of or in connection with your use of the Services, including but not limited to your use of our Marks and other intellectual property rights, or your violation of any rights of any other person or entity. We reserve the right to control the defense of any claim for which STRIDE BP is entitled to indemnification, and you agree to provide STRIDE BP with such cooperation as is reasonably requested by us.
Grant of licences
You hereby warrant and represent that you have the right to use and grant us a license to review any materials regarding your blood pressure device that you submit to us for the purpose of providing the Services. If our review results in an approval of your application, you grant us an exclusive, irrevocable, worldwide, perpetual license to publish such materials and the result of our review on our Site.
This Agreement constitutes the entire and final agreement between you and STRIDE BP and governs your access to the Services, superseding any prior agreements between us with respect to the subject matter of this Agreement. Our failure to enforce any provision of this Agreement will not constitute a waiver of such right. If any provision is found to be invalid, the Parties agree that the court should endeavor to give effect to the Parties’ intentions as reflected in the provision, and that the other provisions of this Agreement remain in full force and effect.
Governing Law and Jurisdiction
This Service provided by the STRIDE BP shall be interpreted in accordance with the laws of Greece. In the event of any controversy or dispute between STRIDE BP and you arising out of or in connection with STRIDE BP’s service, the Parties shall attempt, promptly and in good faith, to resolve any such dispute. If the Parties are unable to resolve any such dispute within a reasonable time (not to exceed thirty (30) days), then any continuing dispute will be resolved by the courts of Athens and in accordance with applicable Greek Law.