| Regulatory Classification and Market Authorization | 20% | Critical | Confirm how the EMS body-shaping device is classified in each target market and whether the supplier's claims match the authorized intended use. | Declaration of conformity where applicable, market-specific registration or clearance records, intended-use statement, labeling, instructions for use, and advertising-claim review. | Complete documentation for every planned sales market; no unsupported fat-reduction, muscle-building, or therapeutic claims. | 5 = complete, current, market-specific file; 3 = minor documentation gaps; 1 = unclear classification or unsupported claims. |
| Electrical and Electromagnetic Safety | 15% | Critical | Assess electrical safety, electromagnetic compatibility, leakage-current protection, grounding, and safe operation in the intended environment. | Applicable test reports, risk-control records, electrical schematics, EMC results, protective-earth verification, and maintenance instructions. | Testing aligned with applicable medical-electrical-equipment requirements, including IEC 60601-1 and IEC 60601-1-2 when applicable to the device classification. | 5 = independent, current reports cover the production configuration; 3 = partial coverage; 1 = self-declared safety only. |
| Risk Management and Usability Engineering | 10% | Critical | Review how foreseeable misuse, contraindications, treatment errors, skin reactions, excessive stimulation, and emergency interruption are controlled. | Risk-management file, hazard analysis, usability-engineering file, contraindication list, emergency-stop design, alarm logic, and user-validation records. | Risk controls should be traceable from hazard identification through verification and user instructions, consistent with ISO 14971 principles. | 5 = traceable and independently reviewed; 3 = usable but incomplete; 1 = generic risk statement without device-specific analysis. |
| Clinical and Performance Evidence | 15% | Critical | Evaluate whether performance claims are supported by appropriately designed testing rather than testimonials or photographic comparisons alone. | Peer-reviewed studies where available, clinical evaluation or performance reports, test protocols, participant criteria, treatment parameters, adverse-event reporting, and follow-up duration. | Evidence should clearly identify the device configuration, treatment protocol, target population, outcome measures, limitations, and observed adverse events. | 5 = relevant controlled evidence; 3 = limited but transparent evidence; 1 = marketing claims without verifiable methodology. |
| Output Consistency and Treatment Control | 10% | Critical | Verify that stimulation intensity, pulse parameters, session duration, applicator placement, and treatment records remain consistent across units and sessions. | Calibration procedure, output-tolerance data, factory acceptance test, software version control, treatment logs, parameter-locking features, and sample verification reports. | Documented tolerances, repeatable output, operator access controls, and a clear process for calibration and out-of-specification results. | 5 = measured and traceable control system; 3 = basic controls; 1 = intensity shown only by an unverified display value. |
| Quality Management System | 10% | Important | Assess design control, supplier control, production records, complaint handling, corrective actions, change management, and document retention. | Current quality-system certificate where applicable, audit summary, inspection records, nonconformance procedure, CAPA examples with confidential details removed, and change-control process. | A documented quality system with traceability from incoming components to finished-device release and post-market complaint handling. | 5 = mature, audited, traceable system; 3 = documented but inconsistently demonstrated; 1 = informal quality controls. |
| Reliability, Warranty, and Serviceability | 8% | Important | Compare expected service life, component replacement, downtime risk, preventive maintenance, warranty exclusions, and service response. | Warranty terms, mean-time or failure data where available, preventive-maintenance schedule, spare-parts list, repair procedures, service-level agreement, and escalation contacts. | Transparent warranty coverage, documented maintenance intervals, replaceable wear components, and defined response times for safety-critical faults. | 5 = measurable service commitments and parts support; 3 = standard warranty only; 1 = unclear repair responsibility. |
| Operator Training and Clinical Support | 5% | Important | Determine whether users receive practical training on screening, contraindications, applicator placement, parameter selection, cleaning, and incident response. | Training syllabus, competency checklist, operating manual, treatment protocols, digital learning records, refresher-training policy, and technical-support procedure. | Training must cover safe patient selection, treatment limits, emergency procedures, documentation, and local professional-scope requirements. | 5 = competency-based training with records; 3 = product demonstration only; 1 = manual supplied without structured training. |
| Data Privacy and Cybersecurity | 3% | Important | Review protection of treatment records, user accounts, connected software, remote support, firmware updates, and access permissions. | Data-flow diagram, privacy policy, access-control design, update process, vulnerability-reporting route, backup policy, and data-processing terms where applicable. | Collect only necessary personal data, use role-based access, protect transmitted data, document updates, and support applicable privacy laws in the target market. | 5 = documented security and privacy controls; 3 = basic password protection; 1 = unmanaged accounts or unclear data handling. |
| Supply-Chain Transparency and Delivery Capability | 2% | Important | Assess component traceability, production capacity, lead-time reliability, packaging, export documentation, and continuity planning. | Bill-of-materials controls, batch or serial-number traceability, production lead-time history, inspection plan, packaging specification, and business-continuity procedure. | Stable production process, documented critical-component controls, realistic lead times, and traceable serial-number records. | 5 = strong traceability and continuity planning; 3 = adequate logistics; 1 = inconsistent delivery or unidentified components. |
| Total Weighted Score | 100% | Overall | Calculate the weighted result using: Weighted Score = Supplier Rating ÷ 5 × Criterion Weight. | Use signed documents, test reports, demonstrations, reference checks, and on-site or remote audits to validate each rating. | Recommended decision rule: shortlist at 80 or above, conditional review at 65–79, and do not approve below 65. | Do not approve any supplier with a rating below 3 in a critical safety, regulatory, or clinical-evidence dimension, regardless of total score. |