Launch & Distribution
With you we ensure compliance all national regulations: e.g. MDR EU regulation (EU) 2017/745, IVDR regulation (EU) 2017/746 for CE Mark, UK Regulations for CA Mark to enable your device(s) placement in your chosen market.
With you we 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
Traceability
Vigilance & regulatory reporting arrangements
Device Installation / Servicing
Device returns
Fulfilment and/or Distributor Agreements
Support Services
- Standard Operating Procedures
- Standards and Regulations
- Distributor Agreements
- Launch Planning
- Distributor Training
- Traceability
- PMS Planning
- Regulatory Clearance
- Fulfilment Agreements
- Distribution Controls
- Distributor Registration
- Audit and Monitoring
Would you like to know more?
We commit to assist you with your enquiries. Please complete the contact form or use on one of the following: