Define your organisation’s activity
Start with the role your organisation performs, then identify the devices, locations and processes within its scope. An organisation may perform several activities; describe each team’s responsibility and how the activities connect.
Importer
Connect device, manufacturer and supplier information to the purchase order, shipment and receipt. This provides a trail of what entered the organisation, how it was checked and where it was stored or sent.
- Products, manufacturers, suppliers and responsibilities for communication.
- Shipment, receipt and checks of device condition and transport conditions.
- Device or batch identification and recipients to support traceability.
Distributor
Organise the movement of each device from receipt to customer delivery while retaining identification and handling information. Collect feedback and complaints and link them to the device, customer and action taken.
- Receipt checks and separation of stock for distribution from stock that needs action.
- Order preparation, delivery and traceability through device and customer information.
- Returns, complaints and communication when corrective action is needed.
Warehouse
Describe storage, receipt and dispatch areas, the devices held and their storage and handling conditions. Link stock movements to receipt, issue and inventory records, and assign responsibility for storage monitoring and deviations.
- Locations, areas, responsibilities and handling equipment.
- Product and batch identification, inventory checks and stock movements.
- Coordination of storage, transport and delivery, including responsibilities when storing products for other organisations.
Authorised representative
Make the relationship with the manufacturer clear through the representation scope, communication channels and responsibilities. Organise documents and correspondence by manufacturer and device so current information and open matters can be followed.
- Representation agreements, contact information and allocation of responsibilities.
- Device information, correspondence and incoming requests.
- Coordination of complaints, safety information and corrective actions with the manufacturer and relevant parties.
Local manufacturer
Link device requirements to production stages, inspection and records of execution. Identify who reviews documents, who monitors the process and how changes and nonconforming results are handled.
- Products, technical files, materials, suppliers and production stages.
- Quality, production and inspection responsibilities, device identification and traceability.
- Complaints, post-sale follow-up, corrective actions and their records.
From activity to package
The medical device quality package addresses system documents, procedures and forms according to the organisation’s activities and information. Prepare a clear description of devices, locations, roles and processes before completing the package questions.