| Regulatory classification and market access |
Clearly documented classification for each intended market; applicable registration, listing, or conformity route completed before commercial shipment. |
Declaration of conformity or equivalent regulatory file, product classification rationale, registration records, and applicable labeling review. |
15% |
Do not accept a generic certificate that does not identify the actual product, intended use, and target market. |
| Quality management system |
A documented quality system covering design control, purchasing, production, inspection, corrective action, and traceability. |
Current third-party audit certificate where applicable, quality manual summary, audit reports, corrective-action records, and controlled procedures. |
15% |
ISO 13485 is the internationally recognized quality-management standard specific to medical devices; verify scope and certificate validity. |
| Material safety and skin contact |
Materials suitable for the intended duration of skin contact, with restricted substances controlled and material changes formally approved. |
Material specifications, supplier declarations, biocompatibility evaluation, chemical-restriction test reports, and change-control history. |
12% |
For prolonged-contact products, review the applicable biological-evaluation rationale rather than relying only on a fabric test. |
| Fit, sizing, and ergonomic design |
At least three clearly defined size ranges or an adjustable design, with measurement instructions and left/right-hand identification. |
Approved drawings, size chart, anthropometric rationale, user-fit evaluation, sample review, and packaging instructions. |
12% |
Check pressure points, thumb mobility, edge finishing, fastening access, and whether the brace can be fitted without assistance. |
| Mechanical performance and durability |
Performance requirements defined for splint stiffness, strap retention, seam strength, repeated fastening, and dimensional stability after care. |
Product-specific test protocol, acceptance criteria, test records, accelerated-use results, and retained production samples. |
12% |
Use written pass/fail limits agreed before sampling; avoid evaluating durability only by visual inspection. |
| Clinical and usability support |
Claims limited to evidence-supported intended use, with user instructions that explain fitting, adjustment, cleaning, warnings, and discontinuation conditions. |
Clinical or usability evaluation summary, risk analysis, instructions for use, complaint trends, and post-market monitoring procedure. |
10% |
Treat pain-relief or therapeutic claims as higher-risk claims requiring stronger supporting evidence and careful wording. |
| Production capacity and lead time |
Capacity, minimum order quantity, standard lead time, peak-season capacity, and replenishment schedule documented in writing. |
Capacity plan, production-flow map, recent delivery records, purchase-order terms, and contingency plan for critical materials. |
8% |
Assess actual on-time delivery performance over recent orders instead of relying solely on quoted lead time. |
| Incoming, in-process, and final inspection |
Documented inspection points for dimensions, materials, stitching, fastening components, labels, packaging, and functional performance. |
Inspection plan, sampling method, calibrated equipment records, batch-release checklist, nonconformance log, and certificate of analysis when relevant. |
7% |
Confirm that inspection records identify lot number, production date, inspector, results, and disposition. |
| Traceability and complaint handling |
Every finished lot traceable to key materials, production records, inspection results, shipment information, and complaint investigation. |
Lot-code structure, mock recall results, complaint procedure, investigation records, corrective-action process, and retention-period policy. |
5% |
A supplier should be able to identify affected lots quickly when a material, labeling, or safety issue is reported. |
| Sustainability and supply-chain resilience |
Documented packaging-reduction goals, responsible-material sourcing, business-continuity planning, and qualified alternatives for critical components. |
Packaging specifications, environmental declarations where available, supplier-risk register, disaster-recovery plan, and dual-source evaluation. |
4% |
Separate verified environmental data from unsubstantiated “eco-friendly” marketing statements. |