Healthcare
Orthopaedics
Orthopaedic product operates under the medical device framework: risk classification, technical documentation and traceability aren't optional.
What we manage
Orthopaedics
Orthopaedic product risk classification
Verification of specific medical CE marking
Reviewing technical documentation and declaration of conformity
Quality control under sterility conditions where applicable
Batch traceability required by the sector
Frequently asked questions
About this
Do you handle custom orthopaedic product or only catalogue items?
Both; custom product requires additional technical documentation, which we also manage.
Which certification is essential in this sector?
It depends on the product's risk class; we confirm this as part of the initial assessment.
Do you work with hospital distributors as the end customer?
Yes, that's a common channel for this type of product.
Healthcare