Quality & documentation
Ask for evidence.
Know what it covers.
Quality documentation is most useful when it relates to your instrument, your supplier and your destination market.
Request documentation ↗Start with the product reference.
Send the references you are evaluating and the country in which you intend to supply them. Specify the documents your procurement or regulatory team needs to review.
Current certificates and product-specific compliance documents are not published on this website. Request the applicable documents and verify their issuer, scope and validity before an order.
Find an instrument reference ↗Include in your documentation request
- Product names and catalogue references
- Destination country and intended sourcing requirements
- Required material and dimensional specifications
- Applicable certificates and declarations
- Instructions for use and reprocessing information, where relevant
Different documents. Different meanings.
ISO 13485 certification
Relates to a medical-device quality management system within a stated scope. Review the certificate holder, scope, issuing body and validity; it is not product approval.
FDA establishment registration
Establishment registration and device listing do not mean FDA approval. Product-specific requirements must be considered separately.
CE marking
Applies to a product under relevant European requirements. Ask for the applicable declaration and supporting documents; a CE graphic alone is not evidence of conformity.
These descriptions explain document types. They do not claim that Surgical Essence or any listed product holds a certification, registration or authorisation.
Further guidance: ISO 13485, FDA registration and listing, and European Commission medical-device guidance.
Let’s start with your instrument list.
Send your references, quantities and destination market. We’ll take it from there.