| Titanium Grade | Confirm whether the plate is commercially pure titanium or a titanium alloy, and whether the selected grade matches the mechanical and biological requirements. | ASTM F67; ASTM F136; ISO 5832-2; ISO 5832-3 | Material certificate showing grade, specification, heat number, chemical composition, and product form. | Grade and specification must be explicitly stated and traceable to the supplied material. | Correct grade selection affects strength, fatigue resistance, corrosion behavior, weight, and tissue compatibility. |
| Chemical Composition | Check titanium content and controlled elements such as aluminum, vanadium, iron, oxygen, carbon, nitrogen, and hydrogen. | Applicable ASTM or ISO material specification | Mill test report plus independent laboratory verification when risk or regulatory requirements justify it. | Every reported element must remain within the limits of the applicable material standard. | Excess interstitial elements or metallic impurities can reduce ductility, fatigue performance, and corrosion resistance. |
| Mechanical Properties | Verify tensile strength, yield strength, elongation, hardness, and thickness tolerance for the actual plate material. | ASTM E8/E8M; ISO 6892-1; applicable grade specification | Test report identifying specimen orientation, thickness, test temperature, method, and results. | For Ti-6Al-4V ELI under ISO 5832-3, commonly referenced minimum values include 860 MPa tensile strength, 780 MPa proof stress, and 10% elongation; confirm the current specification and product form. | Strength and ductility determine resistance to bending, deformation, screw-hole stress, and accidental overload. |
| Plate Geometry | Review length, width, thickness, contour, hole pattern, edge radius, countersinks, slot dimensions, and allowable dimensional tolerances. | Approved engineering drawing; applicable implant or product specification | Dimensioned drawing, inspection report, coordinate-measuring-machine data, and first-article inspection results. | All critical dimensions must meet drawing tolerances, with special attention to screw interfaces and load-bearing sections. | Accurate geometry supports anatomical fit, load distribution, fixation stability, and repeatable surgical or assembly use. |
| Fatigue Performance | Determine whether the finished plate and its intended fixation construct can withstand repeated loading. | ASTM F382; ISO 1099 where applicable | Fatigue protocol stating load ratio, fixture, span, frequency, environment, number of specimens, failure definition, and cycles achieved. | Results should meet the project-defined load and cycle target; fatigue data without test conditions should not be accepted as comparable evidence. | Fatigue resistance is essential when the plate may experience millions of cyclic loads during healing or long-term service. |
| Corrosion Resistance | Assess resistance to localized corrosion, especially for plates exposed to physiological fluids, cleaning chemicals, or dissimilar metals. | ASTM F2129; ISO 10993-15 where applicable | Polarization or corrosion report with electrolyte, temperature, specimen preparation, potential range, and corrosion-current results. | No unacceptable pitting or breakdown under the defined test conditions; acceptance limits must be established for the intended use. | Stable corrosion behavior reduces metal-ion release, surface degradation, and loss of mechanical integrity. |
| Surface Finish | Verify surface roughness, burr removal, edge condition, discoloration, embedded particles, and visible defects. | Approved drawing; validated internal surface specification | Surface-roughness readings, visual inspection records, microscopic inspection where required, and photographs of representative parts. | Surface must be free from cracks, sharp burrs, loose particles, deep scratches, and contamination that could affect use or cleaning. | Controlled surfaces improve cleanability, reduce irritation or wear risk, and help maintain corrosion performance. |
| Biocompatibility Evaluation | Evaluate the finished device, including residues, coatings, processing chemicals, and any patient-contacting surface. | ISO 10993 series; ISO 10993-1 risk-based biological evaluation | Biological evaluation plan, toxicological assessment, material characterization, and applicable test reports. | Evaluation must be based on the final finished and cleaned product, not only on raw titanium material. | Manufacturing residues and surface treatments can change biological risk even when the base alloy is well established. |
| Cleaning and Passivation | Confirm removal of oils, machining debris, polishing compounds, and process residues; verify any passivation or chemical treatment. | Validated cleaning procedure; ASTM F86 where applicable | Cleaning validation, residue limits, ionic contamination results, particulate results, and process records. | Cleaning limits must be defined, validated, and monitored for the final production configuration. | Residual contamination may impair biocompatibility, sterilization, corrosion resistance, or bonding with adjacent components. |
| Sterilization Compatibility | Confirm that the plate, packaging, surface finish, and markings remain stable after the intended sterilization method. | ISO 17665 for moist heat; ISO 11135 for ethylene oxide; ISO 11137 for radiation | Sterilization compatibility report, cycle parameters, packaging validation, and post-sterilization inspection results. | No unacceptable distortion, corrosion, residue, discoloration, loss of marking readability, or package failure after validated cycles. | Repeated or final sterilization exposure can affect packaging integrity, surface condition, and product identification. |
| Manufacturing Process Control | Review machining, laser cutting, forming, additive manufacturing, heat treatment, and inspection controls used for the custom plate. | ISO 13485; ISO 14971; validated process requirements | Process flow, equipment qualification, work instructions, validation records, nonconformance controls, and change-control history. | Critical processes must be validated or verified, with documented controls for deviations and rework. | Consistent process control reduces lot-to-lot variation and prevents hidden defects that may appear during service. |
| Traceability | Ensure the finished plate can be traced from the delivered part back to raw material, processing, inspection, and release records. | ISO 13485; applicable regulatory quality-system requirements | Unique part or lot identification, heat number, certificate of conformity, inspection record, and retained production history. | Critical materials and production steps must be traceable without relying on undocumented verbal records. | Traceability enables effective investigation, recall decisions, corrective action, and long-term service support. |
| Screw and Interface Compatibility | Check hole diameter, thread or locking feature, countersink profile, screw material, torque range, and galvanic compatibility. | Approved system drawing; ASTM F543 where applicable for metallic bone screws | Interface drawing, gauge results, screw-fit verification, torque testing, and mixed-material corrosion assessment where relevant. | Plate and screw interfaces must be dimensionally compatible and tested as the intended complete construct. | Interface mismatch can cause loosening, fretting, stress concentration, galvanic effects, or fixation failure. |
| Environmental and Application Suitability | Define expected load, temperature, humidity, chemicals, cleaning agents, implantation duration, and contact with other materials. | Application-specific risk analysis; ISO 14971 | Use profile, load assumptions, risk analysis, compatibility assessment, and accelerated or simulated-use testing where justified. | Test conditions should represent the worst credible service environment rather than only nominal laboratory conditions. | Realistic service assumptions improve confidence that the custom plate will remain safe and functional throughout its intended life. |
| Regulatory and Documentation Readiness | Verify that the documentation package supports the destination market and the product's intended use. | Applicable 2026 regulatory requirements; ISO 13485; ISO 14971; relevant device standards | Technical file sections, risk-management file, declarations, certificates, test reports, labeling data, and change history. | All claims must be supported by current, product-specific evidence and controlled revision records. | Complete documentation reduces approval delays and supports future audits, modifications, and field investigations. |
| Supplier Change Control | Determine how changes to alloy source, tooling, machining parameters, surface treatment, packaging, or subcontractors will be managed. | ISO 13485 change-control principles; contractual quality agreement | Written notification procedure, change-impact assessment, revalidation triggers, and approval responsibilities. | No critical change should be implemented without documented impact assessment and required requalification. | Controlled changes help preserve fit, strength, surface condition, biocompatibility, and regulatory status over time. |