Device Complaints Sample Clauses

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.
Device Complaints. Xxxxx shall maintain a system of Product complaint recording and reporting and will record the details of any Product complaints received. X.Xxxxx will send to Supplier monthly summary reports of all complaints received. Supplier will provide Product training regarding common complaints that may be received. X.Xxxxx will also communicate with customers regarding the common complaints received. X.Xxxxx will consult with Supplier on complaints which are unique or new to X.Xxxxx. Supplier shall be responsible for supporting X.Xxxxx’x investigation of such complaint reports that are unique or new to X.Xxxxx. Supplier shall, within thirty (30) days after Supplier receives the initial complaint support request from X.Xxxxx, forward the findings of the investigation to X.Xxxxx. In cases where complaints are reported directly to governmental officials, X.Xxxxx will notify Supplier and Supplier’s EC representative simultaneously.
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.
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.
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.

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.

  • Investigatory Interview When the employee under investigation is to be interviewed concerning the alleged conduct which could result in discharge or other discipline, the employee and his or her representative shall be notified in writing, at least forty-eight (48) hours prior to the interview. In the event of an emergency, such reasonable notice as the circumstances permit shall be given. The notice shall state that an official investigation is being conducted and shall state the subject matter of the investigatory interview. a. Prior to being interviewed pursuant to this section, the employee shall be afforded a reasonable opportunity and facilities to contact and consult privately with his or her union representative or union attorney. b. Any interview of an employee under this section shall be conducted at a reasonable time, at a suitable location and, when practicable, on the department’s premises when the employee is on duty. The union representative or union attorney may participate in the interview. c. The interview shall be limited to questions that are directly, narrowly, and specifically related to the employee’s job performance as it relates to the allegation(s) or complaints. The employee shall not be subjected to any offensive language nor be threatened with transfer, dismissal or other disciplinary action. Confidentiality of the interview shall be maintained.

  • Investigatory Interviews ‌ A. Upon request, an employee has the right to a union representative at an investigatory interview called by the Employer, if the employee reasonably believes discipline could result. An employee may also have a union representative at a pre-disciplinary meeting. If the requested representative is not reasonably available, the employee will select another representative who is available. Employees seeking representation are responsible for contacting their representative.

  • Complaints Process The School shall establish and adhere to a process for resolving public complaints which shall include an opportunity for complainants to be heard. The final administrative appeal shall be heard by the School's Governing Board, except where the complaint pertains to a possible violation of any law or term under this Contract. The complaints process shall be readily accessible from the School’s website, as described in Section 11.4.1.

  • COMPLAINTS AND GRIEVANCES 7.01 If an employee has a complaint concerning the application, interpretation, administration, or alleged violation of any of the provisions of this Agreement, he/she shall take the matter up orally with his/her immediate Supervisor or designate within five (5) business days after the circumstance giving rise to the complaint. The Supervisor or designate will give his/her answer to the 7.02 If such complaint or question is not settled to the satisfaction of the employee, then the following steps of the grievance procedure may be invoked in order. It is understood that a grievance must be lodged within five (5) business days after receiving the Supervisor’s or designate response to the complaint as per article 7.01. STEP 1 Any employee grievance shall be set forth in writing, in duplicate, and shall be presented to the Supervisor. The submissions shall include reference to the specific clause and article of the Agreement allegedly violated or misinterpreted and redress sought. The Supervisor shall review the grievance and reply in writing to the Union within five (5) business days, giving his/her disposition and his/her reason thereof. STEP 2 If a settlement has not been reached under Step 1, the employee may within five (5) business days of the Supervisor's reply, refer the grievance to the Administrator of the Home, at interest, or his/her nominee. The Administrator of the Home or his/her nominee together with the employee and his/her Supervisor, and his/her Xxxxxxx, shall meet within five (5) business days of reference to the Administrator of the Home. The Administrator of the Home shall give his/her reply in writing to the Union within five (5) business days after date of meeting. STEP 3 If settlement has not been reached under Step 2, the employee may refer the grievance to his/her Union Grievance Committee which may within five (5) business days of the Administrator's reply refer the grievance to the Director of Human Resources or his/her designate. Within five (5) business days the Director of Human Resources or his/her designate together with such other representation as may be chosen to represent the Employer shall meet with the Union Grievance Committee to discuss the grievance. At this meeting a full-time representative of the Union may be present, if his/her presence is requested by the Employer or the Union. Written reply to the grievance shall be given to the Union within five (5) business days after such meeting. If a grievance is not settled to the satisfaction of either party to this Agreement by the procedure outlined above, then either party may, within ten (10) working days of the reply of the Director of Human Resources, refer the grievance to arbitration in accordance with the provisions contained in Article 9. 7.03 Any of the time allowances provided in the Article may be extended by mutual agreement in writing between the Union and the Employer. 7.04 Notwithstanding the provisions of the Ontario Labour Relations Act, any grievance not initiated or appealed at any stage of the grievance procedure, including reference to arbitration within the limits stipulated, shall be considered settled on the basis of the last decision and NOT subject to further appeal. 7.05 No employee written reprimand shall be entered in an employee's personnel file unless the employee and Local Recording Secretary or designate are given a copy of such written reprimand. 7.06 Saturdays and Sundays and paid holidays shall not be considered working days within the scope of this Article.

  • Complaints and Appeals As a Premera member, you have the right to offer your ideas, ask questions, voice complaints and request a formal appeal to reconsider decisions we have made. Our goal is to listen to your concerns and improve our service to you. If you need an interpreter to help with oral translation, please call us. Customer Service will be able to guide you through the service. We would like to hear from you. If you have an idea, suggestion, or opinion, please let us know. You can contact us at the addresses and telephone numbers found on the back cover. Please call us when you have questions about a benefit or coverage decision, our services, or the quality or availability of a healthcare service. We can quickly and informally correct errors, clarify benefits, or take steps to improve our service. We suggest that you call your provider of care when you have questions about the healthcare they provide.

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