Healthcare sourcing under the regulatory framework this sector demands, with no shortcuts.
We manage sourcing of medical devices, hospital equipment, orthopaedics and medical consumables with the technical documentation and regulatory compliance medical device regulation demands.
Regulatory compliance, not just price.
Medical CE marking
Verifying CE marking and the product's risk classification.
Technical documentation
Declaration of conformity and the product's technical file.
Batch traceability
Batch tracking in line with medical device requirements.
ISO 13485 verification
Checking the manufacturer's quality management system when applicable.
Sterility & storage
Specific transport conditions when the product requires it.
EU Authorized Representative
Guidance on this regulatory requirement in the European market.
Regulation first, logistics second.
Regulatory classification
We determine the risk class and requirements that apply to the product.
Factory & quality audit
We verify the manufacturer's quality management system.
Document verification
We check the declaration of conformity and technical file.
Specific logistics
We coordinate transport conditions when the product requires it.
About this sector
Do you handle medical devices of any risk class?
We assess each case individually; documentation and verification complexity increases with the device's risk class.
Do you verify the manufacturer's ISO 13485 certification?
Yes, verifying the manufacturer's quality management system is part of the audit process for this sector.
Do you help with the EU Authorized Representative requirement?
We can advise on this regulatory requirement and coordinate with medical-regulatory specialists when the project needs it.
Do you handle products that require cold chain or sterility?
Yes, we coordinate specific transport and storage conditions when the medical product requires it.