Medical Device Reporting. Pursuant to governmental medical device ------------------------ reporting regulations (e.
Medical Device Reporting. Should Stellartech become aware of any information relating to product function and/or safety that may be reportable to US FDA under 21 CFR Part 803 (Medical Device Reporting) or to a member of the EEA under MDD Vigilance such information shall be reported to Thermage immediately. In Section 7 of the Development and Supply Agreement, Section 7.4 is added to read in its entirety as follows:
Medical Device Reporting. The Party that is considered the legal manufacturer shall be responsible for reporting to the relevant Regulatory Agency and/or FDA all Complaints and Adverse Events relating to the Product that are required to be reported under FDA medical device reporting regulations, 21 CFR Part 803, as amended.
Medical Device Reporting. Purchaser shall be responsible to report events in compliance with FDA Medical Device Reporting Regulation set forth in 21 CFR Part 803 and any applicable international regulations. Purchaser agrees to make Medical Device Reports available to Supplier within three (3) days of the initial receipt of any report that reasonably suggests that one of the Products (i) may have caused or contributed to a death or serious injury or (ii) has malfunctioned.
Medical Device Reporting. Pursuant to governmental medical device reporting regulations (e.g. the FDA’s Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), the parties may be required to report to the applicable agency information that reasonably suggests that the products contemplated hereunder may have caused or contributed to the death or serious injury or has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. R2 shall be primarily responsible for evaluating any such reportable incidents that relate to the R2 Product, and VTAL shall be primarily responsible for evaluation of any reportable incidents that relate to the VTAL Workstation. Each of R2 and VTAL agree to supply to the other any information relating to such reportable incident promptly after becoming aware of it so that each of R2 and VTAL can comply with governmental reporting requirements.
Medical Device Reporting. Customer shall be solely responsible for reporting all medical device and malfunction reports as defined in 21 C.F.R. § 820, relating to the Product. To the extent Xxxxxx Group has or receives any information regarding any medical device and malfunction report that may be related to the use of the Product, Xxxxxx Group shall immediately, and in no event later than two (2) business days of receipt by Xxxxxx Group, provide Customer with all such information. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Medical Device Reporting. For the purposes of medical device reporting per Title 21 part 803 of the Code of Federal Regulations, Suneva shall be considered a distributor (per 21 CFR § 803.3(g)) of the Products. As such, Suneva acknowledges the requirements set forth for a distributor under 21 CFR part 803, including requirements regarding complaint records.
Medical Device Reporting. Pursuant to the FDA’s Medical Device Reporting (MDR) Regulations, and corresponding regulations of regulatory authorities outside the United States, each Party may be required to report to regulatory authorities information that reasonably suggests that a CyberHeart Product or CyberKnife Component may have caused or contributed to the death or serious injury or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Accordingly, each Party agrees to supply to the other Party all such information, promptly after becoming aware of it, sufficient to enable such other Party to comply with all Applicable Laws, including governmental reporting requirements. Each Party shall cooperate as reasonably requested by the other Party to establish processes and procedures with respect to such reporting, and delivery of information relating to, such issues, and each Party shall comply with the procedures established.
Medical Device Reporting. Pursuant to governmental medical device reporting regulations (e.g. the FDA’s Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), the parties may be required to report to the applicable agency information that reasonably suggests that the products contemplated hereunder may have caused or contributed to the death or serious injury or have malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. R2 shall be primarily responsible for evaluating any such reportable incidents that relate to the R2 Lung CAD Product. Each of R2 and Vital agree to supply to the other any information relating to such reportable incidents promptly after becoming aware of them so that each of R2 and Vital can comply with governmental reporting requirements.
Medical Device Reporting. The Reseller shall provide Todos with reports of any adverse events and product problems in accordance with the Mandatory Medical Device Reporting regulations of 21 CFR 803.
