Consumables
Specification-led medical procurement
Boston Scientific Device Documentation, Without the Detour
Review consumables, infection-control products, and dental equipment through the fields procurement, clinical, biomedical, and regulatory teams need to resolve.
Review fields
What the procurement record must resolve
Values vary by SKU and destination market. The table identifies the evidence package to request, not a blanket claim for every device.
Regulatory identity
Device identityCommercial name, catalog number, unique device identification (UDI), UDI-DI / GTIN, version or revision, and manufacturing site.
Market statusApplicable 510(k) substantial equivalence record, premarket approval (PMA) record, or CE MDR 2017/745 declaration by SKU and indication.
Sterility and handling
Sterility assuranceMethod, validation standard, sterility assurance level (SAL) target where applicable, shelf life, package integrity, and storage conditions.
Use boundarySingle-use device (SUD) or reusable status, reprocessing validation, material contact, contraindications, and disposal route.
Receiving and traceability
Lot controlUDI-PI, lot / serial trace, labeling language, recall contact, adverse event reporting (MDR), and complaint-handling route.
Acceptance recordCertificate set, IFU revision, packaging inspection, quantity reconciliation, nonconformance escalation, and post-market surveillance (PMS) linkage.
Portfolio routes
Two product families, four decision views
Infection control
Reprocessing Inputs
Dental equipment
Chairside Systems
Oral health
Digital Workflow
Decision controls
Six checks before a device reaches the order line
Identity
Match catalog number, UDI, version, and intended use.
Market
Confirm the destination-market record for the exact SKU.
Sterility
Review method, SAL evidence, package validation, and shelf life.
Workflow
Map storage, setup, reprocessing, training, and disposal.
Economics
Compare acquisition, labor, waste, service, and recall exposure.
Traceability
Define receiving, lot control, complaints, and field action routes.
Documentation routes
Standards referenced by the review
Applicability depends on device class, material contact, sterilization method, software content, and destination market.
510(k) or PMA record
Request the 510(k) substantial equivalence or premarket approval (PMA) record tied to the SKU and indication; do not treat a company-level statement as product evidence.
ISO 13485 quality records
Review certificate scope, site coverage, expiration date, and the supplier controls relevant to the ordered product.
ISO 14971 risk management
Confirm that risk-benefit analysis, residual risks, warnings, foreseeable misuse, and post-market surveillance (PMS) are reflected in the current IFU.
ISO 10993 biological evaluation
For patient-contacting materials, align biocompatibility testing endpoints with contact type, duration, processing residues, and final packaging.
ISO 11135 or applicable sterilization validation
Where ethylene oxide sterilization is used, review cycle validation, residual limits, load definition, and sterility assurance level (SAL) evidence.
Bring the SKU, market, and use case.
We will route the request to the appropriate product, service, or regulatory documentation path.
Start a Documentation Request