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This generic template is providing the minimum requirements that need to be written on a Distributor Agreement. On this template, some elements are highlighted so you complete them. There is also some section marked in blue which should guide you on what are some elements you can mention.
The final document should still be reviewed and approved prior to use. This can be done internally by a subject matter expert or by a lawyer.
This Distributor Agreement is necessary for Medical Device Manufacturers that are using Distributors to distribute Medical Devices in the European Union.
All necessary requirements to fulfill EU MDR 2017/745 and EU IVDR 2017/746 were reviewed and included. Reference to ISO 13485 is also provided.
Below you can see the table of content.
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