Medical Equipment Industry Terminology

“We executed ASTM F1980 at 55°C for 6 weeks to justify a 2‑year shelf life”; “Accelerated and real-time aging run in parallel for packaging validation”; “Aging data were included in the sterilization validation report.”

“The patient experienced a serious AE during use; we opened an MDR investigation.”; “All AEs were captured in the clinical study CRFs and assessed for device relatedness.”; “The vigilance team evaluates AEs weekly for signal detection.”

“Based on mucosal contact >24 h, cytotoxicity, sensitization, and irritation were required.”; “We justified systemic toxicity testing via a toxicological risk assessment.”; “Extractables/leachables supported biocompatibility for our drug‑device combination.”

“The engineering BOM rolls up into the manufacturing BOM in ERP.”; “A component change required BOM revision and ECO approval.”; “BOM accuracy is audited under ISO 13485.”

“Complaint trend triggered a CAPA to address catheter hub cracking.”; “We used 5 Whys and fishbone in the CAPA root‑cause analysis.”; “Effectiveness checks confirmed the preventive action worked.”

“Our Class IIb device obtained CE Mark under EU MDR via NB X.”; “Labeling and IFU must display the CE symbol and NB number.”; “CE renewal is aligned with our surveillance audit schedule.”

“The CER synthesizes clinical literature and PMS data to show benefit‑risk.”; “Our CER includes a PMCF plan per EU MDR Annex XIV.”; “Biannual CER updates are in the PMS plan.”

“All complaints are assessed for reportability under 21 CFR 803.”; “We logged the complaint, initiated an investigation, and trended by failure mode.”; “Complaint data feed our CAPA and risk files.”

“The premarket submission included SBOM, threat modeling, and update plan.”; “We implemented secure boot and signed firmware.”; “A coordinated vulnerability disclosure program is in place.”

“We filed a De Novo after our 510(k) had no suitable predicate.”; “Granting created a new regulation and special controls.”; “Future 510(k)s can now cite our De Novo as predicate.”

“User needs were traced to inputs in the RTM.”; “Verification shows outputs meet inputs; validation confirms user needs.”; “Design transfer released DMR to manufacturing.”

“The DHF contains plans, inputs, outputs, V&V, and risk files.”; “Auditors sampled the DHF for traceability.”; “Each major design change updates the DHF.”

“Verification confirmed flow rate meets the input of 5 ± 0.5 mL/min.”; “Summative usability validation passed with critical tasks error‑free.”; “Process validation covered IQ/OQ/PQ for sealing.”

“The DHR shows lot 231 met all in‑process and final inspection criteria.”; “We attached sterilization certificates to the DHR.”; “Missing torque record in the DHR prompted a deviation.”

“The DMR includes drawings, specifications, and assembly/test procedures.”; “Labeling specs are controlled in the DMR.”; “A DMR change required an ECO and QA approval.”

“Testing to IEC 60601‑1‑2 confirmed immunity and emissions limits.”; “Wireless coexistence was assessed per ANSI C63.27.”; “We mitigated ESD failures by redesigning the PCB layout.”

“Transition from MDD to MDR required a deeper clinical evidence package.”; “MDR introduced UDI and stronger PMS obligations.”; “We registered device data in EUDAMED where modules are available.”

“Our Traditional 510(k) referenced two predicates.”; “Special 510(k) used for a design change with same intended use.”; “We demonstrated SE with performance bench testing.”

“DFMEA highlighted a high‑risk failure in the pump motor.”; “We converted RPN use to align with ISO 14971 risk acceptability.”; “PFMEA fed the control plan for manufacturing.”

“Winning the Vizient contract boosted IDN adoption.”; “Our GPO pricing tiers are volume‑based.”; “We aligned our launch with Premier’s sourcing cycle.”

“Our cloud module signs a BAA with covered entities.”; “We de‑identify data before analytics to meet HIPAA Safe Harbor.”; “Cyber controls address HIPAA Security Rule safeguards.”

“NICE guidance influenced NHS uptake.”; “An ICER review raised questions on cost‑effectiveness.”; “Our value dossier supports payer HTA submissions.”

“We conducted formative studies on the pen injector UI.”; “Summative validation addressed critical tasks and use errors.”; “Residual use‑related risks were documented per IEC 62366‑1.”

“The power supply redesign addressed creepage and clearance.”; “Essential performance was defined for alarm functions.”; “CB scheme testing supported global approvals.”

“The IDE allowed us to ship non‑approved devices to sites.”; “We filed a significant risk IDE for the pivotal study.”; “IDE annual reports summarized safety and progress.”

“We converted to eIFU for the professional‑use product line.”; “IFU revisions were controlled under the labeling SOP.”; “Human factors findings drove IFU warnings and graphics.”

“Our PCR assay falls under IVDR Class C in the EU.”; “The instrument, reagents, and software comprise the IVD system.”; “CLIA categorization impacts U.S. deployment.”

“We achieved ISO 13485:2016 certification through MDSAP.”; “Supplier controls were strengthened to meet ISO 13485 7.4.”; “The QMS aligns with ISO 13485 and the FDA QMSR.”

“UDI-DI and UDI-PI are printed on the pouch label.”; “Marketing claims were reviewed for regulatory compliance.”; “IFU updates required NB notification for Class IIb.”

“We secured a new CPT code to enable outpatient reimbursement.”; “HTA and budget impact models supported coverage decisions.”; “Contracting with IDNs and GPOs accelerated adoption.”

“Canada requires MDSAP certification for licensing.”; “Our MDSAP audit covered ISO 13485 plus US, AU, JP, BR regs.”; “Nonconformities were categorized per MDSAP grading system.”

“We submitted a 30‑day MDR for a serious injury event.”; “Trend reports were evaluated for 803.50(a)(2) triggers.”; “MDR evaluations are documented in the complaint file.”

“Our NB issued the EU MDR certificate for the Class IIa line.”; “Capacity constraints at NBs affected timelines.”; “We changed NBs and completed a transfer audit.”

“The PMA included pivotal clinical evidence and bench testing.”; “We filed a PMA supplement for the design change.”; “Panel‑track supplement required an advisory committee.”

“PMS plan defines complaint trending, CAPA triggers, and PMCF.”; “We issue a PSUR for higher‑risk devices in the EU.”; “PMS findings updated the risk management file.”

“We selected a predicate with the same intended use and similar tech characteristics.”; “Differences were addressed via performance testing.”; “The FDA accepted our predicate citing SE.”

“Our QMS covers design, purchasing, production, and PMS.”; “Internal audits found gaps in supplier controls.”; “Management review tracked QMS KPIs and complaints.”

“We’re updating procedures to align with FDA’s QMSR by 2026.”; “Design controls are unchanged but terminology maps to ISO 13485.”; “Supplier controls were harmonized with ISO clauses.”

“A Class I recall was posted to FDA’s database.”; “Our strategy was a field correction with customer letters and IFU updates.”; “Health hazard evaluation supported the recall classification.”

“Securing a Category I CPT code improved hospital adoption.”; “HCPCS Level II code supports ambulatory payment.”; “DRG mapping affects inpatient economics.”

“Hazard analysis identified foreseeable misuse scenarios.”; “Risk controls and residual risk acceptability were justified.”; “PMS data feed into risk management review.”

“Our algorithm is SaMD that runs on a smartphone.”; “We applied IEC 62304 and IEC 82304‑1 for lifecycle and safety.”; “Change management follows a risk‑based approach for SaMD updates.”

“Customers requested our SBOM to assess vulnerabilities.”; “The FDA premarket file included an SBOM and patch plan.”; “We monitor NVD for CVEs tied to our SBOM components.”

“We validated to an SAL of 10⁻⁶ for EtO.”; “SAL target dictated bioburden and sterilization cycle design.”; “Packaging integrity supports maintaining SAL through shelf life.”

“Gamma dose mapping confirmed adequate penetration.”; “BI half‑cycle studies supported EtO sterilization.”; “Requalification is performed annually per standard.”

“Intended use and tech characteristics were compared side‑by‑side.”; “Differences were mitigated via performance testing to show SE.”; “FDA concurred with SE; device is cleared.”

“Annex II/III structure used for our MDR technical documentation.”; “GSPR checklist mapped requirements to evidence.”; “NB audit sampled our technical file for clinical evidence.”

“We submitted UDI data to GUDID and applied the carrier on labels.”; “Basic UDI‑DI groups our family in EUDAMED.”; “UDI‑PI encodes lot and expiration.”

“15 naïve users performed critical tasks without serious use errors.”; “Residual use‑related risks were acceptable.”; “We updated the IFU based on validation findings.”

“We reported a serious incident to the competent authority within 10 days.”; “Trend reporting triggered a vigilance submission.”; “An FSN was issued to customers as part of the corrective action.”