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, Buyer 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 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. In the event that Patient is in need of any medical device, this device may be ordered by Wild Health. The full cost of the device and any additional shipping or service fees will be the responsibility of the Patient and will be charged to the Patient’s account and due monthly with Patient’s Subscription fee
Medical Devices. In the period 2004 to 2005, the medical device manufacturing and development industry consisted of 1’101 facilities, comprising approximately 998 firms. Medical device manufacturing and development facilities were generally small as more than half (57%) had fewer than 25 employees and 37% had from 25 to 49 employees. Of the remaining facilities, only 45 (4%) were of medium size (50-150 employees), and less than 1% were large (greater than 150 employees). Approximately 90% of the medical device facilities were Canadian owned, unchanged from 2002. Foreign-owned facilities tended to be larger as 21% had 50 or more employees, compared to just 4% of domestically-owned facilities. 42% of the medical device industry is located in Ontario, 32% in Quebec. Canada’s exports of medical devices increased at a solid compound annual growth rate of 10.5% from 2000 to 2005. The country’s nearly 1'000 medical devices manufacturing and development firms generated sales of CND 4 bn in 2003, with exports representing 52% of total sales. The US market accounted for 76% of all exports in 2005, followed by the UK (4%), Germany (3%) and China (2%). Leading medical device companies as Baxter, 3M, Bard, McKesson, St. Jude, Siemens, Mitroflow and Tyco have invested in Canada. As Industry Canada states, they have capitalized on low costs, generous R&D incentives and a progressive regulatory regime. Under the Food and Drugs Act, Health Canada defines a device as "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in:
Medical Devices. The Company is in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Radiation Control for Safety and Health Act of 1968 (the “Safety Act”) relating to medical devices. Each device that the Company manufactures, causes to be manufactured and distributes or causes to be distributed for sale (the “Company Devices”) is the subject of a 510(k) premarket notification which resulted in a finding of substantial equivalence by FDA or such device qualifies for exemption from 510(k) premarket notification requirements or is subject to a Pre-Market Approval (“PMA”) by the FDA. None of the Company Devices found substantially equivalent by the FDA have been modified in such a manner as to require the submission of a new 510(k) premarket notification. The Company believes that none of the Company Devices have been labeled or promoted in such a manner as to require the submission of a new 510(k) notification or a new PMA. All the Company Devices being commercialized are listed with the FDA and have been manufactured in a facility registered by the Company with FDA. The Company has obtained the necessary regulatory approvals for its manufacturing facility, and the facility currently has no outstanding adverse inspections or audits. All Company Devices manufactured by the Company or which the Company causes to be manufactured by third parties are manufactured in accordance with applicable Quality Systems Regulations, 21 C.F.R. Part 820. The Company believes it has submitted all reports necessary to be submitted in accordance with the Medical Device Reporting regulations, 21 C.F.R. Part 803. The Company has labeled and promoted the Company Devices in accordance with the provisions of the FDC Act and FDA’s implementing regulations. The Company Devices are not misbranded, adulterated, or otherwise in violation of the FDC Act or FDA’s regulations, or rule governing the current business of the Company or its subsidiaries.
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.
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);