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OEM/PLM collaboration under the new MDR

Discussion in 'EU Medical Device Regulations' started by alexamine90, Apr 17, 2019.

  1. alexamine90

    alexamine90 New Member

    Apr 17, 2019
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    Currently i am writing my master thesis and the topic I am working on is OEM (original equipment manufacturing)-PLM (private label manufacturing) business and contract manufacturing.

    Accoding to the new MDR the PLM must hold control over the complete technical documentation of the OEM. This would not be feasible. How can the OEM protect its intellectual property if they have to share the complete technical file with their PLM customers?
    Currently, I am trying to devise some strategies that would keep the OEM-PLM business alive in the future. After conducting some research on the topic I have become conversant with the following potential solutions: distribution, legal manufacturer change, split, password and trustee models.

    I would be really grateful if you would be willing to share with me some new potential strategies PLM partners could employ to meet the EU MDR requirements and continue to work with their OEM partners.

    Hoping to hear from you soon and thanking you in advance for your response.

    Best regards

    Alexandra Medrea