Device Complaints Clause Samples

Device Complaints. BAS shall maintain a system of product complaint recording and reporting wherein it will record the details of product complaints it receives. BAS agrees to send copies of the complaint reports relating to substantial design, technical or quality issues to SHPI. SHPI shall be responsible for supporting BAS's investigation of such complaint reports. SHPI shall, within thirty (30) days after SHPI receives the initial complaint reports from BAS, forward the findings of the investigation to BAS.
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Device Complaints. (a) Access shall be responsible for handling all complaints, inquiries and any medical or non-medical device reporting requirements associated with the Devices. Access or its Affiliates will be responsible for maintaining Device complaint files and for submitting reports to the FDA regarding such complaints. Access is responsible for complying with all Applicable Laws pertaining to the reporting of adverse device events or malfunctions, including FDA’s Medical Device Reporting requirements, as set forth at 21 C.F.R Part 803. AMAG shall cooperate fully with Access to enable Access to fulfill such requirements. Access shall provide AMAG with a copy of any response related to a request for information from FDA’s Office of Surveillance and Biometrics for AMAG’s review and comment prior to submission of the response. Access shall provide AMAG with a copy of the final response promptly after it is submitted to FDA. (b) If AMAG receives any information regarding real or potential adverse reactions or malfunctions of the Device(s) or any information that might otherwise constitute a complaint about the Device(s), AMAG shall promptly provide to Access all information that it has concerning same. AMAG shall, at Access’s request, assist with the investigation of complaints by requesting reasonably obtainable follow-up information from its customers. Upon the request of AMAG, AMAG and Access shall promptly enter into a separate agreement to further specify the allocation of responsibilities set forth in this Section 4.4(b). (c) In the event and to the extent that [***] manufacture, handling, storage or testing of the Devices facilities, [***], Access shall delegate to AMAG it responsibilities for complaint handling and MDR reporting under 21 C.F.R. Part 803, until [***]. Access shall cooperate fully with AMAG to enable AMAG to fulfill such requirements and shall promptly provide access to existing complaint files and MDRs. Once AMAG [***], all complaint handling and MDR reporting shall [***] with respect to Devices manufactured [***] but not with respect to Devices manufactured [***]. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Device Complaints. ▇▇▇▇▇ shall maintain a system of Product complaint recording and reporting and will record the details of any Product complaints received. ▇.▇▇▇▇▇ will send to Supplier monthly summary reports of all complaints received. Supplier will provide Product training regarding common complaints that may be received. ▇.▇▇▇▇▇ will also communicate with customers regarding the common complaints received. ▇.▇▇▇▇▇ will consult with Supplier on complaints which are unique or new to ▇.▇▇▇▇▇. Supplier shall be responsible for supporting ▇.▇▇▇▇▇’▇ investigation of such complaint reports that are unique or new to ▇.▇▇▇▇▇. Supplier shall, within thirty (30) days after Supplier receives the initial complaint support request from ▇.▇▇▇▇▇, forward the findings of the investigation to ▇.▇▇▇▇▇. In cases where complaints are reported directly to governmental officials, ▇.▇▇▇▇▇ will notify Supplier and Supplier’s EC representative simultaneously.
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Device Complaints. BAS shall maintain a system of product complaint recording and reporting wherein it will record the details of product complaints it receives. BAS agrees to send copies of the complaint reports relating to substantial design, technical or quality issues to SSC. SSC shall be responsible for supporting BAS's investigation of such complaint reports. SSC shall, within thirty (30) days after SSC receives the initial complaint reports from BAS, forward the findings of any investigations to BAS.
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Device Complaints. EXEL shall maintain a system of product complaint recording and reporting wherein it will record the details of product complaints it receives. EXEL agrees to send copies of the complaint reports relating to substantial design, technical or quality issues to SHPI. SHPI shall be responsible for supporting EXEL's investigation of such complaint reports. SHPI shall, within thirty (30) days after SHPI receives the initial complaint reports from EXEL, forward the findings of any investigations to EXEL.
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Device Complaints. Tyco Healthcare shall maintain a system of product complaint recording and reporting wherein it will record the details of product complaints it receives. Tyco Healthcare agrees to send copies of the complaint reports relating to substantial design, technical or quality issues to SHPI. SHPI shall be responsible for supporting Tyco Healthcare's investigation of such complaint reports. SHPI shall, within thirty (30) days after SHPI receives the initial complaint reports from Tyco Healthcare, forward the findings of any investigations to Tyco Healthcare.
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Related to Device Complaints

  • Product Complaints Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;

  • Complaints If you have a complaint relating to the sale of energy by us to you, or this contract generally, you may lodge a complaint with us in accordance with our standard complaints and dispute resolution procedures. Note: Our standard complaints and dispute resolution procedures are published on our website.

  • Delays and Complaints Delivery delays and service complaints will be monitored on a continual basis. Documented inability to perform under the conditions of the contract, via the Complaint to Vendor process (PUR 7017 form) contemplated for this Contract, may result in default proceedings and cancellation.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Customer Complaints Each party hereby agrees to promptly provide to the other party copies of any written or otherwise documented complaints from customers of Dealer received by such party relating in any way to the Offering (including, but not limited to, the manner in which the Shares are offered by the Dealer Manager or Dealer), the Shares or the Company.