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