| Relevant product experience |
Experience supplying the specific categories of spinal implants, instruments, or related products you require. |
Review product documentation, service history, and references from comparable healthcare organizations, where available. |
How long have you supplied this product category, and what support do you provide after delivery? |
| Quality management system |
A current quality-system certificate, such as ISO 13485, when applicable to the supplier’s role and operations. |
Check the certificate’s issuing body, validity dates, sites, and scope. Confirm that the scope covers the relevant activities and products. |
Can you provide the certificate and explain which locations and activities it covers? |
| Regulatory status |
Evidence that the product’s regulatory pathway and market authorization are appropriate for the destination market and intended use. |
Check applicable regulator records and product documentation. Requirements vary by product and jurisdiction. In the United States, FDA establishment registration or device listing alone does not mean that a device is FDA-approved. |
What regulatory authorization applies to this product in the market where it will be used? |
| Authorized supply chain |
The supplier’s role in the supply chain and its authorization to distribute the products, where authorization is required. |
Request current authorization documents and confirm them with the legal manufacturer or relevant authorized party. |
Are you the manufacturer, an authorized distributor, or another type of supplier? |
| Traceability and records |
The ability to trace products using applicable identifiers, such as lot, batch, or serial numbers, and to maintain relevant distribution records. |
Review sample records, labeling, and procedures for order history, returns, and safety notices. |
What information can you provide to trace a supplied product from receipt to delivery? |
| Complaint and recall handling |
Documented processes for receiving complaints, escalating product concerns, and communicating relevant field actions or recalls. |
Ask for a description of the procedures and how customers are notified. Check public regulator safety notices where relevant. |
Who should be contacted to report a product concern, and how are urgent notices communicated? |
| Training and technical support |
Role-appropriate product training and technical support, delivered by qualified personnel and consistent with the product’s instructions for use. |
Review training materials, personnel qualifications, support availability, and any limits on the supplier’s clinical role. |
What training and technical support are included, and who provides them? |