| Quality Management System | ISO 13485:2016 | Valid certificate issued by an accredited certification body; stated scope should cover the design, manufacture, packaging, or distribution activities relevant to cohesive bandages. | Certificate is current, scope is relevant, legal manufacturer is clearly identified, and the certification body can be independently verified. | Critical | 20% |
| EU Medical Device Compliance | Regulation (EU) 2017/745, Medical Device Regulation (MDR) | EU Declaration of Conformity, product classification rationale, technical documentation index, labeling samples, risk-management records, and applicable conformity-assessment documentation. | Documentation is consistent with the intended purpose, risk class, packaging configuration, and claims. Classification is justified rather than assumed. | Critical | 18% |
| CE Marking and Conformity Assessment | CE marking under the applicable MDR conformity route | CE label artwork, Declaration of Conformity, and, where required by device class or sterile status, the relevant notified-body certificate. | CE marking is supported by traceable conformity records. A notified-body certificate is available when required; non-sterile Class I devices may follow a different route. | Critical | 15% |
| Biological Safety | ISO 10993 series; commonly including ISO 10993-1, ISO 10993-5, ISO 10993-10 or applicable current replacements | Biological evaluation plan and report, material composition, skin-contact duration assessment, cytotoxicity data, irritation or sensitization assessment, and toxicological justification where applicable. | Testing and evaluation match the actual patient-contacting materials, contact duration, adhesives, dyes, coatings, and intended use. ISO 10993 testing is not treated as a one-size-fits-all package. | Critical | 15% |
| Material and Chemical Control | Product specifications, supplier controls, and applicable chemical restrictions | Bill of materials, technical data sheets, restricted-substance declarations, adhesive and pigment information, incoming inspection records, and change-control procedure. | All skin-contacting materials are identified and controlled. Material substitutions require documented evaluation before implementation. | Critical | 8% |
| Product Performance | Documented internal specifications and validated test methods | Test reports for cohesive grip, unwind force, conformability, tensile strength, elongation, shedding, edge integrity, and bandage retention after application. | Performance limits are defined before production, test methods are repeatable, and results meet the buyer-approved specification across representative production lots. | Critical | 8% |
| Packaging and Shelf Life | Validated packaging process; shelf-life and stability justification | Packaging specification, seal or closure inspection records, transport testing where applicable, accelerated-aging rationale, real-time stability plan, and storage conditions. | Packaging protects the product throughout declared shelf life. Expiry dating is supported by documented stability evidence rather than a generic industry assumption. | Critical | 6% |
| Sterility Status | Declared sterile or non-sterile status; applicable sterilization validation if sterile | Clear product declaration, sterilization method and validation records where relevant, sterility assurance information, and sterile-barrier integrity data. | Product claims, packaging, labeling, and validation records are consistent. Non-sterile products are not marketed with unsupported sterile claims. | High | 5% |
| Traceability and Batch Release | ISO 13485 traceability and production-control principles | Lot-number system, batch manufacturing records, certificates of analysis or conformity, release criteria, retained-sample procedure, and complaint traceability. | Each shipment can be traced to raw materials, production date, inspection results, packaging configuration, and release authorization. | Critical | 5% |
| Labeling and Instructions | MDR Annex I information requirements and destination-market rules | Label and instruction-for-use files covering intended purpose, application method, precautions, contraindications where applicable, lot number, expiry date, storage conditions, and manufacturer details. | Content is accurate, legible, language-compliant for each target market, and consistent with the technical file and product claims. | Critical | 5% |
| Post-Market Surveillance | MDR post-market surveillance, vigilance, and corrective-action requirements | Post-market surveillance plan, complaint-handling procedure, trend analysis, vigilance escalation process, field-action procedure, and periodic review records. | Complaints are investigated within documented timelines, adverse-event escalation criteria are defined, and corrective actions are tracked to closure. | Critical | 4% |
| Manufacturing Capacity and Supply Continuity | Validated production processes and business-continuity controls | Production-capacity statement, process-flow diagram, equipment-maintenance records, backup-supplier strategy, lead-time history, and business-continuity plan. | Capacity is demonstrated using realistic monthly output, quality yield, lead-time data, and contingency arrangements rather than nominal machine capacity alone. | High | 4% |
| Change Control | ISO 13485 design and process-change controls | Formal change-control procedure covering materials, suppliers, equipment, manufacturing parameters, artwork, packaging, and intended-use claims. | Buyer notification and regulatory-impact assessment are required before changes that may affect safety, performance, labeling, or conformity. | Critical | 3% |
| International Market Readiness | Destination-country regulatory and import requirements | Regulatory registration support, authorized-representative information where required, customs documentation, multilingual labeling capability, and export-quality records. | Documentation can be adapted to the buyer’s target markets without changing unsupported claims or creating inconsistencies between markets. | High | 4% |