Glossaire de l'achat de dispositifs médicaux
510(k) Clearance
An FDA regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. 510(k) clearance is required b...
CE Marking
A certification mark indicating that a product conforms to EU health, safety, and environmental protection standards. For medical devices, CE marking ...
Compliance Matrix
A structured document mapping every tender requirement to the supplier's response, compliance status, and supporting evidence. The compliance matrix i...
EU MDR (Medical Device Regulation)
European Union Medical Device Regulation 2017/745, the current regulatory framework governing medical devices in the EU. EU MDR replaced the Medical D...
Evidence Chain
A traceable link between a compliance claim in a tender response and the source document that proves it. Evidence chains include the specific document...
GPO (Group Purchasing Organization)
An organization that aggregates purchasing volume from multiple healthcare facilities to negotiate better pricing and contract terms with medical devi...
KOL (Key Opinion Leader)
A respected expert in a medical field whose opinions influence clinical practice, treatment guidelines, and procurement decisions. In medical device a...
Notified Body
An organization designated by an EU member state to assess the conformity of medical devices before they can be placed on the market. Notified Bodies ...
Predicate Device
A legally marketed medical device to which a new device is compared in a 510(k) submission to establish substantial equivalence. The predicate device ...
RAG (Retrieval-Augmented Generation)
An AI architecture that retrieves relevant documents from a knowledge base before generating responses, grounding every output in verifiable source ma...
Regulatory Compliance
The adherence of medical devices to applicable laws, regulations, and standards in each market where they are sold. In tender response, regulatory com...
Correspondance des spécifications
Le processus de comparaison des exigences d'un appel d'offres avec les spécifications produit pour déterminer la conformité. La correspondance par IA ...
Tender Automation
The use of AI and software to automate stages of the tender response process, including requirement extraction, spec matching, evidence gathering, com...
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