Getinge_USA_Sole_Source_Letter.pdf
PDF 134 KB Posted
- Attached to
- Service Plan for Laboratory Sterilizer
- Solicitation number
- S26-0554
- Issued by
- Orange County, Orlando City, Florida
About this file
This is a sole-source justification letter from Getinge USA Sales, LLC regarding laboratory sterilizer service and maintenance in Florida. The contract opportunity, designated as S26-0554, involves a service plan for laboratory sterilizer equipment with a due date of Wednesday, August 12, 2026, at 2:00 pm. The posting period for alternative suppliers to challenge the sole-source designation runs for seven calendar days from the announcement date of Tuesday, August 4, 2026. Any potential suppliers believing they can provide equivalent products or services must submit product information, statements of qualifications, and capability documentation to the purchasing agent within this seven-day window.
Getinge USA positions itself as the exclusive source for original equipment manufacturer (OEM) replacement parts, accessories, and authorized service for its sterilization equipment. The company emphasizes its qualifications through continuous ISO 9001 and ISO 13485 certification since 2006, FDA clearance under 510K approval processes, and a trained and certified field service technician network. Getinge's service offerings include scheduled and unscheduled maintenance, a field service escalation process for complaint resolution, and performance metrics including response time guarantees, preventative maintenance schedule compliance, and first-time fix rates. The company maintains a global complaint tracking and trending system aligned with 21 CFR Part 803 requirements and utilizes third-party customer satisfaction measurements through md Buyline analytics.
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Other files
| File | Type | Posted |
|---|---|---|
| Service_Plan_for_Laboratory_Sterilizer.pdf |
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Text version
Getinge USA Sales, LLC
1 Geoffrey Way
Wayne, NJ 07470
USA
888-627-8383 www.getinge.com
January 1, 2024
Dear Valued Customer, As the equipment manufacturer, Getinge USA Inc. (Getinge) is the sole-source supplier of factory authorized OEM (original equipment manufacturer) replacement parts and accessories for your equipment. Getinge OEM parts are tested for performance, longevity, and cost effectiveness. They are service parts which meet OEM operational requirements and provide the best performance life in application of use.
As the service division of the original equipment manufacturer, Getinge’s field service team is held to a higher service standard. Getinge products are cleared by the FDA under the guidelines of the 510K approval process. When serviced by a Getinge service program over its lifetime, the equipment will meet OEM specifications.
Getinge Care Service is the sole-source for OEM technicians who are trained and certified to perform scheduled and unscheduled maintenance on Getinge equipment. To assure customer satisfaction and ensure equipment performance, Getinge has a Field Service Escalation process.
The purpose of which is to establish an effective method for escalating a customer concern or problem to the necessary management level. The process details levels of service support from the field starting with support from a regional senior service representative to a Service Operations Specialist. The process has triggers based upon the elapsed time of implementing the repair.
ISO Certification
Getinge has maintained an uninterrupted certification to the ISO standards for quality management systems 9001 and 13485 since 2006. ISO 13485 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Complaint Handling
As required by the Code of Federal Regulations, 21 CFR part 803, Getinge defines a complaint as any alleged deficiency as defined by the customer. We also consider all unplanned (non-preventive maintenance) service calls complaints. Each time an unplanned service call is conducted the information is transferred into a Getinge Global complaint system. Each complaint is reviewed and each investigated. The highest level of our organization has visibility to this system. The system also has a track and trend feature, enabling our equipment design
Getinge USA Sales, LLC
1 Geoffrey Way
Wayne, NJ 07470
USA
888-627-8383 www.getinge.com team and manufacturer(s) to anticipate potential problems before they result in customer downtime. Tracking and trending provides an input to continual product/service improvement.
Quality Measures
Getinge has identified internal and external KPI (Key Performance Indicators) of which customer feedback is crucial. Customer satisfaction is measured in variety of ways. Getinge utilizes md Buyline whose independent metrics provide an unbiased report card.
Service Metrics
– Response time for service requests – Measured and reviewed regularly is our commitment to a PM Schedules - A measurement and review of Getinge’s Service performance to on-time preventative maintenance schedules.
– First Time Fix- The newest of the service metrics intended to drive fix it right the first time.
Getinge provides the power of a global company serving our customers for over 125 years. We think you will agree that our courteous, responsive Customer Support Center staff and our North American network of trained local service representative will enable you to get the most from your equipment investment.
Call us at 888-627-8383
File details come from the government source that posted it. Updated .