Medical Devices. This Article applies when the Goods and/or Services involve UC purchasing or leasing one or more medical devices from Supplier, or when Supplier uses one or more medical devices in providing Goods and/or Services to UC. Medical Device as used herein will have the meaning provided by the U.S. Food and Drug Administration (“FDA”) and means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (i) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; (ii) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (iii) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Supplier warrants that prior to UC’s purchase or lease of any Medical Device or Supplier’s use of any Medical Device in providing Goods and/or Services hereunder, Supplier will: (i) perform security testing and validation for each such Goods and/or Services or Medical Device, as applicable; (ii) perform a security scan by an anti-virus scanner, with up-to-date signatures, on any software embedded within any Goods and/or Services or Medical Device, as applicable, in order to verify that the software does not contain any known viruses or malware; (iii) conduct a vulnerability scan encompassing all ports and fuzz testing; and (iv) provide UC with reports for (i) – (iii). Supplier warrants that all security testing performed by Supplier covers all issues noted in the “SANS WE TOP 25” and/or “OWASP Top 10” documentation. Throughout Supplier’s performance of this Agreement, Supplier will provide UC with reasonably up-to-date patches, firmware and security updates for any Medical Device provided to UC, and any other Medical Device used in the course of providing Services, as applicable. All such patches and other security updates will be made available to UC within thirty (30) days of its commercial release or as otherwise recommended by Supplier or Supplier’s sub-supplier, whichever is earlier. Supplier warrants that all software and installation media no...
Medical Devices. Employees wishing to suggest additional safety equipment or to raise issues with regard to current equipment (e.g. availability, training needs, effectiveness) are encouraged to raise such suggestions through management or with appropriate committees - Nursing QA & I, Health and Safety, Infection Control, or Product Evaluation.
Medical Devices. If any of the Products are medical devices, Buyer acknowledges that it is familiar with the U.S. Safe Medical Devices Act of 1990 (the “Devices Act”) and the reporting obligations imposed on device users thereunder. In this regard, Xxxxx agrees to notify Crosstex within 10 days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or Crosstex (except for events representing an imminent hazard that require notification to the U.S. Food and Drug Administration (the “FDA”) within 72 hours (or such shorter time as required by law), in which case, such notice will be delivered to the FDA and Crosstex within said period). Buyer will maintain adequate tracking for the Products to enable Crosstex to meet the FDA requirements applicable to the tracking of medical devices.
Medical Devices. This Section applies when the Goods and/or Services involve UC purchasing or leasing one or more medical devices from Supplier, or when Supplier uses one or more medical devices in providing Goods and/or Services to UC.
Medical Devices. If any of the Products are medical devices, Buyer acknowledges that it is familiar with the U.S. Safe Medical Devices Act of 1990 as amended (the “Devices Act”) and the reporting obligations imposed on device users thereunder. In this regard, Buyer agrees to notify MEDIVATORS within ten (10) days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or MEDIVATORS (except for events representing an imminent hazard that require notification to the United States Food and Drug Administration (the “FDA”) within seventy-two (72) hours (or such shorter time as required by law), in which case, such notice will be delivered to the FDA and MEDIVATORS within said period). Buyer will maintain adequate tracking for the Products to enable MEDIVATORS to meet the FDA requirements applicable to the tracking of medical devices.
Medical Devices. This Article applies when the Goods and/or Services involve UC purchasing or leasing one or more medical devices from Supplier, or when Supplier uses one or more medical devices in providing Goods and/or Services to UC. Medical Device as used herein will have the meaning provided by the U.S. Food and Drug Administration (“FDA”) and means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
Medical Devices. Unless otherwise agreed to in writing, Buyer warrants that the Goods or services subject to this Contract are not intended for use as components or components of assemblies used in implantable medical devices, are not finished medical devices, and are not medical devices requiring U.S. Federal Food and Drug Administration approval or other governmental approval.
Medical Devices. (a) Each Party agrees that, if any of its Products is subject to regulation as a medical device by the FDA, then such Party will fulfill all corresponding regulatory requirements, including full compliance with all applicable Laws related to premarket clearance or approval, manufacturing, marketing, sale, and distribution of the Products (and upon the other Party’s request, such Party will promptly provide the other Party’s with any such clearance or approval documentation to support the marketing of the Products);
(b) Neither Party will seek any licenses, permits, or approvals or make any determinations that may result in any of the other Party’s products or service being deemed regulated as a medical device or that may impose any obligations or limitations on the other Party with respect to the regulatory status of any of the other Party’s products or services; and
(c) if a Party decides to seek any licenses, permits, or approvals or to take any action that may result in its Products being deemed regulated as a medical device or that may impose any obligations or limitations on any of its Products with respect to its Products’ regulatory status, then such Party will immediately notify the other Party, and will use their commercially reasonable efforts to minimize the effect of such regulation, obligation, or limitation, to the extent reasonably practicable.
(d) Known specific regulatory requirements and licenses, permits or approvals for each Product shall be identified in the applicable Product Schedule.
Medical Devices. This Article applies when the Goods and/or Services involve UC purchasing or leasing one or more medical devices from Supplier, or when Supplier uses one or more medical devices in providing Goods and/or Services to UC. Medical Device as used herein will have the meaning provided by the U.S. Food and Drug Administration (“FDA”) and means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (i) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; (ii) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (iii) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Supplier warrants that prior to UC’s purchase or lease of any Medical Device or Supplier’s use of any Medical Device in providing Goods and/or Services hereunder, Supplier will: (i) perform security testing and validation for each such Goods and/or Services or Medical Device, as applicable;
Medical Devices. If any of the Products are medical devices, Buyer acknowledges that it is familiar with all relevant legal and regulatory rules and requirements having the force of law (collectively, “Relevant Legislation”) and the reporting obligations imposed on device users thereunder. Where any Relevant Legislation requires Buyer and/or Endocarts to report any hazard or other matter in connection with the Products to a regulatory authority or government body (collectively, “Authority”), then Buyer will notify the Authority and Endocarts within the period specified by the Relevant Legislation. Buyer will maintain adequate tracking for the Products to enable Endocarts to comply with Relevant Legislation in relation to the tracking of medical devices.
