Medical Device Procurement Glossary
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...
Bid Management
The end-to-end process of identifying, qualifying, preparing, submitting, and tracking tender and bid opportunities. In medical device sales, bid mana...
CE Marking
A certification mark indicating that a product conforms to EU health, safety, and environmental protection standards. For medical devices, CE marking ...
Clinical Evaluation
A systematic and ongoing process of collecting, appraising, and analyzing clinical data to verify the safety, clinical performance, and clinical benef...
Compliance Matrix
A structured document mapping every tender requirement to the supplier's response, compliance status, and supporting evidence. The compliance matrix i...
Conformity Assessment
The process by which a manufacturer demonstrates that a medical device meets the applicable regulatory requirements. Under EU MDR, conformity assessme...
De Novo Classification (FDA)
An FDA regulatory pathway for novel, low-to-moderate risk medical devices that have no legally marketed predicate device. De Novo creates a new regula...
EU Declaration of Conformity
A legally binding document in which a medical device manufacturer declares that their product meets all applicable requirements of EU MDR 2017/745. Th...
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...
EUDAMED (European Database on Medical Devices)
The EU's centralized database for medical device information, including UDI registration, certificates, clinical investigations, vigilance reports, an...
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...
FDA Medical Device Recall
An action taken by a manufacturer or the FDA to remove or correct a medical device that violates FDA regulations or poses a risk to health. Recalls ar...
GPO (Group Purchasing Organization)
An organization that aggregates purchasing volume from multiple healthcare facilities to negotiate better pricing and contract terms with medical devi...
HSA (Health Sciences Authority, Singapore)
Singapore's regulatory authority responsible for the registration and oversight of medical devices, pharmaceuticals, and health products. HSA operates...
IEC 60601 — Medical Electrical Equipment Safety
The international standard series governing the safety and essential performance of medical electrical equipment. IEC 60601-1 is the general standard,...
ISO 13485 — Quality Management Systems for Medical Devices
The international standard specifying requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to pro...
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...
Medical Device Directive (MDD)
The former EU regulatory framework (93/42/EEC) for medical devices, replaced by EU MDR 2017/745. MDD certificates issued by Notified Bodies remain val...
Medical Device Risk Classification
The system by which regulatory authorities categorize medical devices based on their potential risk to patients and users. Risk classification determi...
MHRA (Medicines and Healthcare products Regulatory Agency, UK)
The UK's regulatory authority for medicines, medical devices, and blood products. Post-Brexit, MHRA operates independently from the EU regulatory fram...
NMPA (National Medical Products Administration, China)
China's national regulatory authority responsible for approving and overseeing medical devices, pharmaceuticals, and cosmetics. NMPA registration is m...
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 ...
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Japan's regulatory agency responsible for reviewing and approving medical devices and pharmaceuticals. PMDA conducts pre-market reviews (Shonin approv...
Post-Market Clinical Follow-up (PMCF)
A continuous process of proactively collecting and evaluating clinical data on a medical device after it has been placed on the market. PMCF is a mand...
Post-Market Surveillance (PMS)
A systematic process for collecting, analyzing, and acting on information about medical devices after they have been placed on the market. PMS is a re...
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 ...
Premarket Approval (PMA)
The most stringent FDA regulatory pathway for medical devices, required for Class III devices that pose the highest risk. PMA requires clinical trial ...
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...
Request for Proposal (RFP)
A formal procurement document issued by a healthcare organization inviting suppliers to submit detailed proposals for medical devices or services. RFP...
Request for Quotation (RFQ)
A procurement document requesting suppliers to submit pricing for specified medical devices or services. Unlike an RFP, an RFQ focuses primarily on pr...
Spec Matching
The process of comparing tender requirements against product specifications to determine compliance. AI-powered spec matching uses semantic understand...
Technical Documentation (MDR)
The comprehensive set of documents that a manufacturer must compile to demonstrate a medical device's compliance with EU MDR requirements. Technical d...
Tender Automation
The use of AI and software to automate stages of the tender response process, including requirement extraction, spec matching, evidence gathering, com...
TGA (Therapeutic Goods Administration, Australia)
Australia's regulatory authority for therapeutic goods including medical devices. TGA manages the Australian Register of Therapeutic Goods (ARTG) and ...
Unique Device Identification (UDI)
A globally harmonized system for identifying medical devices throughout their distribution and use. UDI assigns a unique numeric or alphanumeric code ...
Your next tender
is due Friday.
Bring fifty line items. Leave with a submission-ready file.