Every Device Verified. Every Biological Evaluation Traceable.
Medical device manufacturers worldwide operate at the intersection of patient safety and regulatory scrutiny — from FDA and EU MDR to PMDA, TGA, Health Canada, and NMPA. LIMSera provides the test data management, DHF population, and multi-market submission-ready documentation infrastructure to bring devices to market globally — without compliance shortcuts.
When Device Test Data Lives In Silos, Your Design History File Is A Liability.
Medical device manufacturers face the same documentation paradox across every major market — FDA, EU MDR, PMDA, TGA, Health Canada, NMPA. Regulatory submissions demand complete, traceable evidence from every test stage, yet most companies manage biocompatibility results in spreadsheets, sterilisation validation in shared drives, and finished device test records in isolated QMS modules with no linkage to design outputs. When a notified body, FDA reviewer, or PMDA auditor asks for the traceability matrix, someone manually assembles it — under deadline pressure, with the risk of missing a critical link.
ISO 10993 biological evaluations require endpoint-by-endpoint justification. Sterilisation validation requires BI lot traceability, D-value calculations, and dose audit records. Design verification requires each test result mapped back to its design output and risk control. None of this can be pieced together reliably from disconnected systems without significant manual effort and audit risk.
LIMSera integrates ISO/IEC 17025-accredited laboratory testing with design control, risk management, and multi-market regulatory document assembly — so your DHF builds itself as testing progresses, and your technical file is submission-ready for every target market simultaneously.
Every Testing Domain Your Device Development Requires
Pre-configured for biocompatibility, material characterisation, sterilisation validation, and finished device testing across all risk classifications.
Biocompatibility
Assess cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation, haemocompatibility, and pyrogenicity for every device material in direct or indirect patient contact. LIMSera manages ISO 10993 test matrices, maps material and device classifications, tracks reference materials and positive controls, and links biological evaluation reports directly to the design history file. Physicochemical characterisation endpoints — extractables and leachables — are managed with chemical identity thresholds and toxicological risk assessment linkage.
The Device Testing Workflow, End To End
Design Verification
Design outputs are entered with acceptance criteria. LIMSera generates a test plan from the device classification and intended use, maps each design output to a test method, and assigns work orders. V&V matrix populated automatically.
Sample Receipt & Preparation
Test samples are registered against device version, lot number, and material composition. Preparation instructions are loaded from the procedure library. Sample conditioning, sterilisation, and pre-test inspections are recorded with operator attribution.
Testing & Data Capture
Tests are executed with guided protocols. Raw data from instruments is captured electronically or via manual entry with audit trails. Biological indicator readings, mechanical test outputs, and chemical analysis results are structured per ISO/IEC requirements.
Data Review & Trending
Results are reviewed against acceptance criteria with automatic pass/fail determination. Trend charts highlight parameter drift across lots. Out-of-specification investigations are triggered with root cause analysis workflows.
QA Approval
Results flow through a configurable multi-level review: analyst self-check, technical reviewer, and QA approval. Electronic signatures are 21 CFR Part 11 / EU Annex 11 compliant. Each approval captures timestamp, reviewer identity, and review statement.
DHF Report Generation
Approved results populate the Design History File automatically. Verification and validation reports, biological evaluation summaries, and sterilisation validation dossiers are assembled into submission-ready documents with full data traceability.
Everything Your Medical Device QA Function Needs
Design History File Integration
LIMSera populates the Design History File automatically as test results are approved. Design verification and validation (V&V) data, biocompatibility results, sterilisation validation, and finished device tests are linked to their corresponding design outputs and risk controls.
Device Master Record Linkage
Device specifications, component drawings, material certifications, test procedures, and acceptance criteria maintained in a structured Device Master Record. Revisions are version-controlled with change history and approver attribution.
ISO/IEC 17025 & ISO 13485
Laboratory testing workflows built for ISO/IEC 17025 accreditation alongside ISO 13485 QMS and 21 CFR Part 820 QSR. CAPA, nonconformance, calibration, measurement uncertainty, and audit trail — all integrated.
Risk Management Integration
ISO 14971 risk file linkage to test results. Hazard identification, risk estimation, mitigation measures, and residual risk acceptance tied to test evidence. Risk benefit analysis documentation traceable to laboratory data.
Biocompatibility Test Matrix
ISO 10993-1 biological evaluation framework with device categorisation, contact nature/duration classification, test endpoint mapping, and study waiver documentation. Toxicological risk assessments linked to test data and exposure estimates.
Sterilisation Process Parameters
Parametric release-ready process parameter recording for steam and radiation sterilisation. EO cycle parameter capture with residual limits. Biological and chemical indicator result logging with reject-and-hold workflows.
Clinical Evaluation Data Management
Post-market clinical follow-up (PMCF) data captured alongside pre-market clinical investigation results. Performance evaluation data structured for IVDR/MDR technical documentation requirements.
Complaint & Vigilance Integration
Post-market complaint data linked to test methods and device lot records. Vigilance reporting workflows for serious incident investigations with field safety corrective action (FSCA) documentation.
Shelf-Life & Stability Scheduling
Real-time ageing and accelerated ageing study scheduling per ASTM F1980. Pull-down alerts, study completion workflows, and packaging integrity trending across time points.
Global Regulatory Submission
CE mark (EU MDR 2017/745), FDA 510(k)/PMA, PMDA (Japan), TGA (Australia), Health Canada, NMPA (China), and CDSCO technical documentation assembled from LIMSera records. Summary tables, test data appendices, and traceability matrices generated automatically per target market.
From Design Inputs To Verified Outputs. Every Test Linked. Every Gap Visible.
LIMSera implements the medical device design control framework with full traceability from user needs and design inputs through design outputs, verification tests, and validation studies. When a design output is created, LIMSera generates the corresponding V&V test plan automatically — assigning work orders, loading test procedures, and populating the verification and validation matrix.
As tests are executed and approved, results flow directly into the DHF. Completeness dashboards show which design outputs are fully verified, which are in progress, and which have no test coverage. Before a regulatory submission, the traceability matrix is generated automatically — showing the unbroken chain from each user need through its risk control to its verification evidence.
ISO 10993 Test Matrices That Build Themselves. Biological Evaluation Reports Ready To Submit.
LIMSera's biocompatibility module starts with device classification. Based on contact type, contact nature, and contact duration, the system generates the ISO 10993-1 test matrix — identifying required endpoints, applicable studies, and justifiable waivers. Study assignments, reference material management, and positive control tracking are all structured within the platform.
Extractables and leachables data is captured with chemical identity mapping, analytical threshold comparisons, and toxicological concern limit assessments. The biological evaluation report is assembled automatically from test data, risk assessments, and literature justifications — ready for inclusion in MDR technical documentation or FDA submission packages.
Technical Documentation That Writes Itself From Your Test Data.
LIMSera transforms approved test records into structured regulatory documents. Summary of safety and performance (SSCP), device description sections, design verification summaries, sterilisation validation overviews, and post-market surveillance plans are generated from structured data rather than manual compilation. Each document section links back to the source test records.
Submission readiness dashboards show documentation completeness per regulatory target — EU MDR Annex II, FDA 510(k) summary, PMDA STED, TGA CTD, Health Canada MDSAP, and NMPA registration dossier. Outstanding items are listed with responsible parties and due dates. When external auditors or notified bodies request evidence, LIMSera provides secure read-only access to the complete, structured technical file.
Regulatory Compliance Infrastructure Built For Medical Devices. Not Adapted From.
ISO/IEC 17025 & 21 CFR Part 11
Full ISO/IEC 17025 accreditation infrastructure — calibration management, measurement uncertainty, proficiency testing — combined with 21 CFR Part 11 audit trails and electronic signatures.
Design Control Integration
V&V test plans generated from design outputs. Results populate the Design History File automatically. Traceability matrices assembled on demand for notified body review.
CAPA & NCR Management
Structured nonconformance and corrective action workflows with root cause analysis, effectiveness verification, and formal closure documentation linked to test records.
Global Technical File Assembly
EU MDR Annex II/III, FDA 510(k)/PMA, PMDA STED, TGA, Health Canada, NMPA, and CDSCO technical documentation assembled from structured test data. Completeness dashboards per market.
Standards We Support
Designed For Every Role In Medical Device Development
Test plan generation from design outputs, V&V matrix population, sample tracking from prototype through design freeze, and design verification report assembly
ISO 10993 test matrix management, extractables and leachables data capture, toxicological risk assessment linkage, and biological evaluation report generation
Validation study templates, BI and PCD tracking, D-value calculations, dose audit protocols, and revalidation alert scheduling
Multi-level approval workflows, NCR and CAPA management, change control, DHF population, ISO/IEC 17025 lab accreditation, and ISO 13485 audit readiness
Multi-market technical documentation — EU MDR/IVDR, FDA 510(k)/PMA, PMDA, TGA, Health Canada, NMPA — risk file integration, and clinical evaluation data
Complaint and vigilance data linkage to test records, PMCF data capture, FSCA documentation, and real-world performance trending
Frequently Asked Questions
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