| PEEK Material | Confirm that the polymer grade is suitable for the intended implant application and that its identity and traceability are controlled. | Material specification, supplier documentation, lot traceability records, and evidence of conformity to ASTM F2026 where applicable. | Check that documentation identifies the material grade, relevant requirements, and a traceable link between incoming material lots and finished devices. |
| Quality Management System | Determine whether the manufacturer operates a medical-device quality management system covering design, production, inspection, and corrective actions. | Current ISO 13485 certificate, certificate scope, audit information, and documented change-control and nonconformance processes. | Verify the certificate’s validity and scope independently; confirm that the activities and product categories relevant to the screw are covered. |
| Regulatory Status | Confirm the regulatory status for the intended markets and the exact device configuration being offered. | Applicable market authorization or registration documents, device classification rationale, labeling, and the legal manufacturer’s details. | Check that documents apply to the specific product and market. Regulatory pathways differ by jurisdiction; do not assume one approval covers every market. |
| Design and Intended Use | Review the intended anatomical application, screw dimensions, thread design, insertion features, and compatibility with the surgical technique. | Controlled drawings, product specifications, instructions for use, dimensional inspection records, and design-change history. | Compare the documented configuration with the intended procedure and instruments; confirm that any custom design is formally controlled and validated. |
| Mechanical Performance | Assess whether performance testing addresses the device’s intended use, including relevant insertion, fixation, and structural characteristics. | Test protocols, acceptance criteria, representative sample information, test reports, and rationale linking tests to intended use. | Look for defined methods and device-specific acceptance criteria. Avoid relying on unsupported claims or results from a different design or material. |
| Biological Evaluation | Review the biological safety evaluation for the finished device, considering its materials, manufacturing residues, and contact conditions. | Biological evaluation plan and report, relevant test reports, and a rationale based on the applicable ISO 10993 framework. | Confirm that the evaluation addresses the finished device and its intended contact, rather than relying only on generic raw-material information. |
| Sterilization and Packaging | Clarify whether the supplied product is sterile or non-sterile and how the sterilization and sterile-barrier system are validated, when applicable. | Sterilization validation and routine-control records; packaging validation documentation, including applicable ISO 11607 evidence for terminally sterilized devices. | Check that the validated process matches the supplied product and packaging. Sterilization validation standards depend on the method used. |
| Risk Management | Check how design, manufacturing, and use-related hazards are identified, evaluated, and controlled throughout the device life cycle. | Risk-management documentation aligned with ISO 14971, including risk controls and evidence that controls were verified. | Look for device-specific risks and traceability from identified hazards to controls and verification—not only a general policy statement. |
| Manufacturing and Inspection | Understand the machining and finishing controls, cleanliness practices, inspection stages, and handling of nonconforming product. | Process flow, equipment qualification or validation records where required, inspection plans, calibration records, and sample batch records. | Confirm that critical dimensions and product characteristics have defined inspection methods and documented acceptance criteria. |
| Traceability and Change Control | Verify traceability from raw material through production and final release, along with notification and review of product or process changes. | Example lot-traceability records, release documentation, change-control procedure, and complaint or recall-handling process. | Ask how a specific finished-device lot can be traced to its material lot, production records, inspections, and release decision. |
| Technical Support and Supply Reliability | Assess responsiveness, technical-document availability, lead-time planning, and procedures for handling supply interruptions. | Documented communication channels, sample evaluation plan, capacity information, and continuity or contingency procedures. | Prefer clear, documented answers and realistic commitments over unverified claims about capacity, delivery, or product performance. |