Quality is not a claim. It is a certified, audited process.
Every instrument that leaves Instrumed is produced under ISO 9001 and ISO 13485-certified systems, CE-marked where applicable, and manufactured to cGMP and FDA quality-system principles — verified through ongoing third-party audit, not self-declared.
CERTIFICATIONS
Five certifications. One standard: no exceptions.
ISO 9001
Quality management system certification
ISO 13485
Medical devices quality management system
CE Marking
Conformity with EU health & safety requirements
cGMP
Current Good Manufacturing Practice
FDA Quality System
US FDA quality system principles
HOW WE VERIFY IT
Quality built in at every stage of manufacture
Incoming material inspection
Raw steel and components are checked against specification before a single instrument enters production.
In-process quality checks
Instruments are inspected at each stage of manufacture, not only at the end of the line.
Final inspection & testing
Every instrument is functionally tested and visually inspected for finish and dimensional accuracy before packing.
Documentation & traceability
Production and batch records are maintained to support traceability on every order.
Need our certificates for a tender or import registration?
We can supply certification documents on request for regulatory and procurement purposes.