OEM means a private label, either custom or a standard product with customer specific requirements, likely to include a customer logo or trademark. But it also means excellent service, cooperative partnership at eye-level, to benefit from high tech, digital clean-room production and long-term partnering.
Eppendorf OEM products are created specifically according to customers requirements but they are not necessarly fully customized. For example, a customer can have a serial twin-tec plate with their own logo.
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Eppendorf OEM does not supply 510k cleared products but can supply products for the purpose of a 510k submission. These are sold to customers as subcomponents of diagnostic tools. Eppendorf OEM can create IVD-ready products for use in clinical applications.
As Eppendorf OEM manufactures multiple products under ISO 13485 and ISO 9001; good documentation practices in conjunction with our quality management system ensures compliance for customers looking to provide instruments or consumables into regulated markets.
Depending on the product, full Design History Files (DHF) and Device Master Records (DMR) can be provided as part of a customers FDA submission. As this is heavily product dependent our experts will check and discuss the requirements with our customers upfront.
Eppendorf OEM can supply IVD-ready products but cannot provide IVD approved products for OEM purpose.
Eppendorf OEM is expert in producing huge quantities (seven billion pieces a year) and is able to adjust to customer needs.
With an OEM product from Eppendorf, the customer has a great deal of control over the manufacturing and life span of the product. One of the biggest values is ensuring control over the materials (raw materials, coatings, components, etc.) and also timing of these manufacturing changes. An OEM product allows both the OEM customer and Eppendorf the critical time needed to manage product changes as they arise.
Eppendorf OEM´s manufacturing facility is fully automated. This allows the production facility to place high quality optics and laser measurements to ensure each piece is made to the correct specifications. Additionally, Eppendorf OEM maintains specific know-how around high precision, high cavity and injection tools/molds. This allows us to ensure high precision manufacturing.
Eppendorf OEM has the ability to provide private label versions of not only off the shelf products but can develop fully customized consumables and in certain cases customized instruments.