Our Testing Methodology
Independent medical device reviews backed by research and real-world testing
Comprehensive, hands-on testing protocols using professional-grade simulators and real-world device evaluation, aligned with recognized medical device standards.
1. Overview & principles
Our testing methodology is designed to provide consumers and healthcare professionals with objective, hands-on assessments of medical devices. Every device undergoes a standardized evaluation process that combines simulator-based measurements with extended real-world usage testing.
Research-Informed
Our evaluations reference peer-reviewed clinical literature, manufacturer data, and established medical device testing standards.
Transparent
Our evaluations reference peer-reviewed clinical literature, manufacturer data, and established medical device testing standards.
Reproducible
Our evaluations reference peer-reviewed clinical literature, manufacturer data, and established medical device testing standards.
2. Standards Compliance
Our testing protocols align with international standards for medical device evaluation and quality management:
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2019
Medical devices — Application of risk management to medical devices
IEC 62366-1:2015
Medical devices — Application of risk management to medical devices
3. Testing Phases
Each device undergoes a comprehensive four-phase evaluation process:
Pre-Testing Assessment
Duration: 1-2 weeks
Simulator & Bench Testing
Duration: 2-4 weeks
Simulator & Bench Testing
Duration: 2-4 weeks
Real-World Usage Testing
Duration: 4-8 weeks
Analysis & Reporting
Duration: 1-2 weeks
4. Data Collection
Our data collection methodology ensures comprehensive, unbiased assessment across multiple dimensions:
Analysis & Reporting
Analysis & Reporting
Technical Specifications
Qualitative Assessment
User Experience
Practical Considerations
Testing Approach
Simulator Testing: Multiple measurement cycles using calibrated medical device simulators
Real-World Testing: Extended usage period (typically 4-8 weeks) to assess reliability
Comparative Analysis: Side-by-side comparison with competing devices when available
Documentation: Detailed logging of test conditions, results, and observations
5. Scoring Methodology
Devices are evaluated across multiple dimensions with weighted scoring based on clinical importance:
Overall Score Interpretation
90-100: Exceptional — Highly recommended
80-89: Excellent — Recommended
70-79: Good — Recommended with reservations
60-69: Fair — Limited recommendation
<60: Poor — Not recommended
Overall Score Interpretation
Grade A: Multiple RCTs or meta-analyses
Grade B: Single RCT or high-quality studies
Grade C: Observational studies or case series
Grade D: Expert opinion or limited data
Grade F: Insufficient evidence
6. Real-World Validation
We validate our findings by comparing test results with published research and real-world user feedback:
Validation Approach
Clinical Literature ReviewComprehensive review of published clinical studies, FDA submissions, peer-reviewed research, and post-market surveillance data for each device.
User Feedback AnalysisAnalysis of verified user reviews, reported issues, and documented experiences from actual device users to identify patterns and common concerns.
Manufacturer Data ReviewEvaluation of manufacturer specifications, clinical validation data, warranty claims, and technical documentation against our test findings.
Comparative AnalysisSide-by-side comparison with competing devices in the same category and established industry benchmarks.
100+
Simulator test measurements per device
8-12
Weeks average testing duration
50+
Research papers reviewed per category
7. Disclosure & Ethics
Transparency and independence are fundamental to maintaining trust in our evaluations:
Independence Policy
Transparency Commitment
We are committed to complete transparency in our testing process and business relationships. Any affiliations, sponsorships, or potential conflicts of interest are clearly disclosed.
Our reviews are based solely on objective testing data and real-world usage experience. Affiliate relationships with retailers do not influence our testing methodology, scoring, or recommendations.
Funding Sources
Our testing program is independently funded through:
Note: We maintain complete independence. Device manufacturers have no input into our testing methodology, evaluation process, or final recommendations. All devices are purchased at retail price.
Limitations
Our evaluations have inherent limitations that should be considered:
Always consult with healthcare professionals for personalized medical device recommendations.
Questions about our methology?
We’re committed to continuous improvement and welcome feedback from healthcare professionals and patients about our testing protocols.
Last Updated: October 2025 | Version 3.0