Medical Device Products. Certain Spacelabs Products may be classified as medical devices. The Customer will have the following additional obligations in conjunction with operation and use of Spacelabs medical devices:
14.7.1. If Customer receives or otherwise becomes aware of information that reasonably suggests that a Spacelabs medical device has been or might be involved in an adverse event or safety-related incident, as defined by applicable laws and regulations from time to time, the Customer will forward such information to Spacelabs without unreasonable delay. Customer will use best efforts to assist Spacelabs with the investigation of any such adverse events or incidents.
14.7.2. If Spacelabs notifies Customer that a field safety corrective action or product recall is required for a Spacelabs medical device, then Customer will expediently confirm receipt of field safety notices or product recall notices, and inform all affected users as instructed by Spacelabs. Customer will also assist Spacelabs in the execution of the field safety corrective action or product recall, including following up with each affected user that required action has been implemented.
14.7.3. If Customer resells the medical devices, Customer will have key processes compliant with regulatory requirements such as but not limited to complaint handling, recalls, traceability, auditing, and equipment testing. Customer will provide Spacelabs with all information reasonably necessary for Spacelabs to evaluate such processes including the ability to audit. Customer will immediately notify Spacelabs of any changes to its key processes.
14.7.4. SPACELABS’ WARRANTY IS VOIDED BY USE OF ACCESSORIES, SPARE PARTS, OR CONSUMABLES THAT ARE NOT QUALIFIED BY SPACELABS AS COMPATIBLE WITH THE MEDICAL DEVICE PRODUCT, AS THE PRODUCT IS IN SUCH INSTANCE NO LONGER COMPLIANT WITH REGULATORY REQUIREMENTS.
Medical Device Products. Certain Spacelabs Products may be classified as medical devices. The Customer will have the following addition al obligations in conjunction with operation and use of Spacelabs medical devices:
16.8.1. If Customer receives or otherwise becomes aware of information that reasonably xxxx ests that a Spacelabs medical device has been or might be involved in an adverse event or safety-related incident, as defined by applicable laws and reg ulations from time to time, the Customer will forward such information to Spacelabs without unreasonable delay. Customer will use best efforts to assist Spacelabs with the investigation of any such adverse events or incidents.
16.8.2. If Spacelabs notifies Customer that a field safety corrective action or product recall is req uired for a Spacelabs medical device, then Customer will expediently confirm receipt of field safety notices or product recall notices, and inform all affected users as instructed by Spacelabs. Customer will also assist Spacelabs in the execution of the field safety corrective action or product recall, including following up with each affected user that req uired action has been implemented.
16.8.3. If Customer resells the medical devices, Customer will have key processes compliant with reg ulatory req uirements such as but not limited to complaint han dling, recalls, traceability, auditing, and eq uipment testing. Customer will provide Spacelabs with all information reasonably necessary for Spacelabs to evaluate such processes including the ability to audit. Customer will immediately notify Spacelabs of any changes to its key processes.
Medical Device Products. Certain Spacelabs Products may be classified as medical devices. The Customer shall have the following additional obligations in conjunction with operation and use of Spacelabs medical devices:
13.6.1. If Customer receives or otherwise becomes aware of information that reasonably suggests that a Spacelabs medical device has been or might be involved in an adverse event or safety-related incident, as defined by applicable laws and regulations from time to time, the Customer shall forward such information to Spacelabs without unreasonable delay. Customer shall use best efforts to assist Spacelabs with the investigation of any such adverse events or incidents.
13.6.2. If Spacelabs notifies Customer that a field safety corrective action or product recall is required for a Spacelabs medical device, then Customer shall expediently confirm receipt of field safety notices or product recall notices, and inform all affected users as instructed by Spacelabs. Customer shall also assist Spacelabs in the execution of the field safety corrective action or product recall, including following up with each affected user that required action has been implemented.
