Showing 19–27 of 32 articles
FDA's Quality Management System Regulation aligns U.S. device quality requirements more closely with ISO 13485. For sterile single-use device suppliers, distributors will look harder at design, purchasing, production, traceability, complaints and CAPA records.
FDA guidance on sterility information in 510(k) submissions gives suppliers a clear reference for sterile-device files. EO-sterilized single-use consumables should be quoted with method, SAL, packaging, shelf-life and labeling information.
A PMC review on trocar-site hernia brings larger-port fascial closure back into surgical consumable discussion. Buyers should review port-size fit, needle-path control, suture compatibility and training clarity.
ASA difficult-airway guidance keeps supraglottic airway devices in the backup-strategy conversation. Single-use laryngeal mask procurement should cover size range, seal information, package identification, shelf life and cart configuration.
FDA guidance on ISO 10993-1 highlights risk-based biological evaluation. Medical-grade silicone tube buyers should review material grade, contact type, supplier traceability, biocompatibility files and change control.
Gastric calibration tube sourcing usually starts with 32–40 Fr sizes, 1200 mm length, radiopaque line, depth markings and the leak-test workflow. This guide helps distributors, hospital projects and OEM/ODM customers build a selection checklist.
Intragastric balloon sourcing for distributors and private hospitals covers more than the balloon itself: capacity, packaging, IFU, the placement and removal workflow, and samples.
An intragastric balloon sourcing guide for distributors, private hospitals and bariatric centers, covering the information to prepare, documents, packaging and labels, samples and OEM/ODM cooperation.
Negative pressure drainage set sourcing should confirm the tube type, guide needle, drainage bag, suction bulb, scale and packaging for surgical drainage projects.