| Intended Use and Device Classification |
Confirm whether the lens is intended for vision correction, accommodative assistance, light transmission control, or another ophthalmic purpose. Determine whether the complete product includes electronics, a power source, software, a frame, or an external controller. |
Documented intended-use statement, preliminary regulatory classification assessment, product architecture diagram, and risk-based classification rationale for each target market. |
The intended use, user population, operating environment, and product configuration are clearly defined and consistent across technical, quality, and commercial documents. |
Intended-use statement, device description, classification rationale, applicable-market list, and explanation of any accessories or companion software. |
High |
Before quotation and whenever the design changes |
| Quality Management System |
Verify that the manufacturing site operates a medical-device quality management system appropriate to the product risk and target markets. |
Current third-party certification to ISO 13485, certification scope, audit history, corrective-action records, and a controlled quality manual or equivalent documentation. |
Certification covers the actual manufacturing and design activities for the electro-active lens or relevant medical-device components. Any certificate exclusions are understood and accepted. |
Certificate, issuing body, scope, expiration date, site address, latest audit summary, open major findings, and corrective-action status. |
High |
Before supplier approval and annually |
| Regulatory Pathway |
Establish the approval, registration, or conformity route in every market where the lens will be sold. Novel electro-active functions may require additional clinical, software, electrical, or performance evidence. |
Regulatory strategy, gap assessment, technical documentation index, pre-submission or authority correspondence where available, and market-specific requirements matrix. |
The supplier provides a written pathway with identified submission responsibilities, required evidence, critical milestones, and ownership of post-market obligations. |
Regulatory plan, target-market matrix, device classification, submission status, registration status where applicable, and list of unresolved regulatory questions. |
High |
Before contract signing and at each design freeze |
| Risk Management |
Check whether hazards related to optical performance, electrical energy, overheating, battery failure, charging, software faults, electromagnetic interference, misuse, and loss of vision correction have been assessed. |
Risk-management file structured around ISO 14971 principles, hazard analysis, fault-tree or equivalent analysis, use-related risk analysis, and verification of risk controls. |
All reasonably foreseeable hazards have documented controls, residual-risk evaluations, verification evidence, and user information where residual risk remains. |
Risk-management plan, risk analysis, benefit-risk assessment, change history, residual-risk summary, and list of safety-critical characteristics. |
High |
At every design review and change assessment |
| Optical Performance |
Verify the stated prescription range, optical power accuracy, optical-center control, transmission behavior, field performance, and switching consistency across the complete operating range. |
Independent optical metrology, spectrophotometry, wavefront or focal-power testing where relevant, repeatability testing, and comparison against applicable ophthalmic-lens standards. |
Measured results meet the approved product specification and applicable optical tolerances. The specification identifies tolerances for every optical state, not only the nominal state. |
Optical drawings, prescription limits, measurement methods, calibration records, tolerance stack-up, test reports, and lot-release criteria. |
High |
Design qualification and every production lot or defined sampling plan |
| Electro-Optical Switching |
Assess switching time, transition behavior, optical-state accuracy, hysteresis, visible artifacts, flicker, unintended switching, and performance under low-temperature, high-temperature, and low-battery conditions. |
Automated time-response testing using calibrated optical instruments, environmental-chamber testing, repeated cycling, and human-factors evaluation of visible or perceptible artifacts. |
Switching performance remains within the approved specification throughout the rated operating conditions and after the defined life-cycle test. |
Switching-time distribution, optical-state data, environmental test results, cycle count, failure modes, control logic, and firmware version. |
High |
Design qualification, firmware release, and periodic production verification |
| Material and Biocompatibility Safety |
Identify all materials that may contact skin, tears, eyelids, or the periocular area, including coatings, adhesives, encapsulants, seals, and residues from manufacturing. |
Material declarations, chemical characterization, extractables and leachables assessment where appropriate, and biocompatibility evaluation based on ISO 10993 principles and the actual contact type and duration. |
No unassessed material, coating, adhesive, or process residue is introduced into the finished product. Biological risks are addressed for the intended contact and use duration. |
Full material list, supplier declarations, safety data sheets, biocompatibility plan, test reports, and change-notification procedure for materials. |
High |
Before design freeze and after any material change |
| Electrical Safety and EMC |
For products containing active electronics or power sources, verify electrical safety, insulation, leakage, charging behavior, electromagnetic compatibility, and immunity to foreseeable electromagnetic disturbances. |
Applicable electrical-safety and EMC test reports, component-level evaluations, battery and charger safety assessments, and testing of the complete system in its intended configuration. |
The complete product passes applicable requirements for normal operation and single-fault or abnormal conditions defined by the risk analysis. |
Electrical schematics, ratings, battery specifications, charger specifications, EMC test plan, test reports, protective measures, and failure-mode analysis. |
High |
Design verification, certification, and after hardware changes |
| Battery and Power-System Reliability |
Confirm battery chemistry, capacity retention, charging cycles, thermal behavior, protection circuitry, storage conditions, transport requirements, and safe end-of-life behavior. |
Battery qualification, charge-discharge cycling, overcharge and short-circuit protection testing, temperature testing, storage-life testing, and transport classification where applicable. |
The power system meets the specified operating time and remains safe after the defined number of charge cycles and environmental exposures. |
Battery datasheet, protection design, cycle-life results, charging profile, operating-time distribution, shipping documentation, and replacement or disposal instructions. |
High |
Design qualification and each battery or charger revision |
| Software and Firmware Controls |
Determine whether firmware, mobile applications, cloud services, algorithms, or connectivity influence optical performance, safety, configuration, or user instructions. |
Software life-cycle documentation based on applicable medical-device software practices, requirements traceability, architecture review, verification records, cybersecurity assessment, and release-control records. |
Safety-critical software requirements are traceable to tests. Version control, rollback, update authorization, anomaly handling, and cybersecurity controls are documented. |
Software bill of materials, version history, requirements matrix, test summary, vulnerability-management process, update policy, and support period. |
High |
Every software release and at least annually |
| Usability and Human Factors |
Evaluate fitting, activation, charging, cleaning, adjustment, warnings, user-interface feedback, failure indication, and use by people with reduced vision or dexterity. |
Use-related risk analysis, formative studies, simulated-use testing, validation testing, labeling review, and assessment against applicable usability-engineering principles such as IEC 62366-1. |
Users can complete critical tasks correctly without relying on undocumented knowledge. Foreseeable misuse does not create unacceptable residual risk. |
Use specification, user profiles, task analysis, validation protocol, test results, labeling, training materials, and complaint trends. |
High |
Before market release and after major interface changes |
| Environmental Durability |
Verify resistance to humidity, sweat, temperature variation, ultraviolet exposure, vibration, impact, bending, cleaning agents, perspiration, and repeated handling. |
Environmental conditioning, ingress assessment where applicable, mechanical shock and flex testing, coating adhesion tests, accelerated aging, and post-conditioning optical and electrical verification. |
Critical optical, electrical, mechanical, and cosmetic functions remain within specification after the defined environmental and mechanical exposures. |
Rated environmental limits, test plans, conditioning profiles, failure criteria, post-test measurements, and accelerated-aging model assumptions. |
High |
Design qualification and periodic requalification |
| Service Life and Reliability |
Establish the expected service life for the lens, electronic module, battery, coatings, connectors, and any replaceable accessories. |
Reliability plan, accelerated life testing, switching-cycle testing, temperature-humidity bias where relevant, failure-rate analysis, and verification of the declared service-life claim. |
The declared service life is supported by test data and clearly states assumptions, duty cycle, storage conditions, maintenance requirements, and excluded conditions. |
Reliability prediction, life-test results, cycle limits, warranty assumptions, preventive-maintenance schedule, and end-of-life indicators. |
High |
Before launch and during annual product review |
| Manufacturing Process Control |
Review control of lamination, encapsulation, alignment, sealing, coating, electrical assembly, optical calibration, firmware loading, and final inspection. |
Process flow, control plan, process-FMEA, validated or qualified processes, work instructions, operator training records, and statistical process-control data for critical characteristics. |
Critical processes are controlled and reproducible. Special processes have defined validation or qualification evidence, and deviations are formally dispositioned. |
Process map, control plan, process-capability data, equipment list, calibration records, training matrix, deviation procedure, and inspection instructions. |
High |
Supplier qualification and quarterly performance review |
| Incoming, In-Process, and Final Inspection |
Confirm that inspection covers raw materials, optical components, electronics, assembled lenses, firmware, packaging, labeling, and release documentation. |
Inspection plans, calibrated equipment, sampling rationale, acceptance-sampling method, first-article inspection, and traceable final-release records. |
No product is released without documented completion of required inspections and tests. Nonconforming product is segregated and controlled. |
Inspection criteria, sampling plan, certificate of conformance template, batch records, calibration certificates, and nonconformance statistics. |
High |
Every production batch |
| Traceability and Change Control |
Verify traceability from raw materials and critical components to finished-lens serial or lot numbers, including hardware, firmware, battery, coating, and packaging revisions. |
Electronic or controlled paper traceability records, lot genealogy, configuration-management procedure, engineering-change procedure, and mock recall exercise. |
Critical components and finished products can be traced within the time required by the applicable quality and regulatory system. Changes are assessed for regulatory and validation impact before implementation. |
Traceability matrix, serial-number structure, change-control workflow, notification period, recall procedure, and sample lot records. |
High |
Before approval and during annual audit |
| Packaging, Sterility, and Shipping |
Determine whether the product is supplied non-sterile or sterile, and verify protection from shock, moisture, electrostatic discharge, contamination, and temperature excursions during transport. |
Packaging validation, distribution simulation, seal or barrier testing where applicable, transport qualification, storage-condition verification, and labeling review. |
Packaging preserves product integrity through the declared distribution cycle and remains compatible with the lens, electronics, battery, and required storage period. |
Packaging drawings, shipping tests, storage limits, moisture controls, ESD controls, shelf-life evidence, and transport instructions. |
Medium |
Before launch and after packaging changes |
| Clinical and Performance Evidence |
Assess whether laboratory performance alone is sufficient for the intended claims or whether clinical evaluation, clinical investigation, or real-world usability evidence is required. |
Clinical-evaluation plan, literature review, clinical investigation documentation where applicable, complaint analysis, and objective assessment of claimed benefits and risks. |
Claims are supported by evidence appropriate to the intended use, risk profile, novelty, and target-market requirements. Marketing language does not exceed validated performance. |
Claim-to-evidence matrix, clinical summary, endpoints, inclusion criteria, adverse-event process, and post-market evidence plan. |
High |
Before making claims and during post-market review |
| Supplier Capacity and Continuity |
Evaluate production capacity, bottleneck processes, second-source availability, critical-component lead times, minimum order quantities, and contingency plans. |
Capacity model, historical delivery data, business-continuity plan, disaster-recovery evidence, supplier-dependency map, and capacity stress test. |
Capacity supports forecast demand with defined headroom. Critical single points of failure have mitigation plans, qualified alternatives, or agreed inventory protection. |
Monthly capacity, lead times, yield trends, minimum order quantities, allocation policy, continuity plan, and escalation contacts. |
High |
Before contract signing and quarterly |
| Cost and Total Cost of Ownership |
Compare unit price with tooling, development, validation, certification, calibration, software, replacement, warranty, training, logistics, and regulatory-maintenance costs. |
Five-year total-cost model using forecast volumes, failure rates, replacement rates, service assumptions, and currency or logistics sensitivities. |
The commercial model identifies one-time and recurring costs and includes assumptions for low-volume production, engineering changes, warranty returns, and end-of-life support. |
Pricing tiers, tooling ownership, non-recurring engineering charges, service fees, warranty terms, spare-parts pricing, and payment milestones. |
Medium |
Before supplier selection and annually |
| Warranty and Field-Service Capability |
Review warranty duration, failure definitions, return-material authorization, repair versus replacement policy, turnaround time, diagnostic capability, and regional service coverage. |
Warranty agreement, service-level agreement, sample failure-analysis reports, return workflow, repair records, and field-failure trend reports. |
Warranty responsibilities, response times, replacement criteria, data ownership, and cost allocation are contractually defined and measurable. |
Warranty period, target turnaround time, first-response time, service locations, spare-parts policy, repair limits, and escalation process. |
High |
Before purchase order and monthly after launch |
| Long-Term Software, Parts, and Documentation Support |
Confirm how long firmware, applications, technical files, replacement batteries, electronic modules, calibration tools, and service documentation will remain available. |
Product-support roadmap, end-of-life policy, software-support commitment, obsolescence-management process, and contractual continuity obligations. |
Support duration is stated in years or tied to a defined market commitment. End-of-life notice, transition support, and compatible replacement rules are documented. |
Support period, update frequency, end-of-life notice period, spare-parts availability, documentation-access rights, and migration plan. |
High |
Before contract signing and annually |
| Post-Market Surveillance |
Ensure the supplier can detect, investigate, trend, and report complaints, adverse events, field failures, battery incidents, software vulnerabilities, and recurring optical defects. |
Post-market surveillance plan, complaint-handling procedure, vigilance assessment, trend-reporting method, corrective-action process, and periodic safety review. |
Defined reporting timelines, investigation responsibilities, escalation thresholds, and data-sharing rules are established for all target markets. |
Complaint rate, return rate, failure codes, corrective-action history, safety notices, field-performance reports, and reporting contacts. |
High |
Monthly or quarterly after launch |
| Data Protection and Cybersecurity |
Assess whether the lens, controller, application, or cloud service collects personal, health, biometric, location, or device-usage data. |
Data-flow diagram, privacy impact assessment, access-control review, vulnerability-management process, penetration testing where appropriate, encryption assessment, and incident-response plan. |
Only necessary data is collected, access is controlled, data is protected in transit and at rest, and security incidents have defined notification and remediation procedures. |
Data inventory, retention policy, authentication method, encryption controls, vulnerability-disclosure process, update mechanism, and incident contacts. |
High |
Before integration and after material software changes |
| Contractual and Audit Rights |
Make sure the purchasing agreement covers quality obligations, regulatory cooperation, change notification, audit access, confidentiality, intellectual property, liability, recalls, and support continuity. |
Quality agreement, supply agreement, service-level agreement, audit reports, corrective-action commitments, and legal review of responsibility allocation. |
All critical obligations have measurable timelines, escalation routes, evidence requirements, and remedies for repeated nonconformance or supply interruption. |
Quality agreement template, audit rights, change-notification period, liability terms, recall-cost allocation, intellectual-property terms, and termination assistance. |
High |
Before supplier approval and at renewal |
| Final Supplier Scorecard |
Use a documented, risk-weighted score rather than selecting solely on price, prototype appearance, or sample performance. |
Weighted evaluation matrix, evidence-completeness review, technical due diligence, on-site or remote audit, sample approval, and cross-functional sign-off. |
Supplier is approved only when critical compliance, safety, quality, capacity, and support criteria are passed or have formally accepted mitigation plans. |
Completed scorecard, open-action list, approval status, accountable owner, target dates, and requalification criteria. |
High |
At supplier selection and at least annually |
