Launch & Distribution

GPB provide support to Distributors and Manufacturers meet the requirements of MDR EU regulation (EU) 2017/745 and IVDR regulation (EU) 2017/746.

We will define and establish plans to implement / enhance efficiencies and demonstrate compliance in:

  • Meeting specific country regulatory requirements e.g. language / labelling

  • Contract Fulfilment Services (Warehousing / Order Processing / Distribution / Returns)

  • Distributor Identification

  • Fulfilment and/or Distributor Registration

  • Fulfilment and/or Distributor Agreements

  • Device Installation / Servicing

  • Traceability

  • Vigilance & regulatory reporting arrangements

  • Device returns

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