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Supporting a Next-Gen Blood Pressure Monitor for FDA 510(k) and EU MDR Validation

A digital health company developed a new generation of automated, cuff-based blood pressure monitors (BPMs) with Bluetooth capability and companion mobile app integration. As a Class II medical device, clinical validation was essential for FDA 510(k) clearance and EU MDR certification.

Client Challenges

  • Capture performance across multiple user populations (age, sex, BMI)
  • Validate data transmission accuracy via mobile app and cloud platform
  • Meet FDA and EU MDR expectations for device safety, accuracy, and usability
  • Conduct a comparative validation study as per AAMI/ANSI/ISO 81060-2:2018 standards
  • Demonstrate equivalence and accuracy against a reference-grade sphygmomanometer

Clinvigilant Research Solution

Study Design & Regulatory Mapping

  • Created a multicenter validation protocol that aligned with:
  • ISO 81060-2 for non-invasive sphygmomanometers
  • FDA 510(k) performance test criteria
  • EU MDR’s General Safety & Performance Requirements (GSPR)
  • Defined primary endpoints:
  • Mean systolic/diastolic differences vs. reference
  • Measurement repeatability
  • User experience feedback (ease of use, discomfort, app connectivity)

Site Selection & Participant Management

  • Engaged 3 investigational sites across the U.S. and 1 in Germany
  • Recruited 100+ subjects covering a broad demographic spread
  • Integrated inclusion/exclusion screening tied to ISO test protocol (e.g., arm circumference diversity, hypertension status)

Data Capture & Device Evaluation

  • Used Clinvigilant's EDC integrated with mobile app logs and timestamped readings
  • Synchronized readings from:
  • Test device
  • Reference device (manual mercury sphygmomanometer)
  • Independent observer assessments
  • Captured errors, calibration checks, connectivity status, and app feedback in real time

Quality Control & Reporting

  • Employed double data entry verification for systolic/diastolic values
  • Monitored protocol deviations and adverse events (e.g., cuff discomfort, missed readings)
  • Prepared:
  • Clinical Validation Report (CVR) for 510(k)
  • Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) for EU MDR

Outcomes

112

Subjects Enrolled

High inter-rater reliability

(ICC > 0.95)

Repeatability

<1%

Connectivity/Data Sync Errors

Within 3 weeks post DB lock

Time to 510(k) Submission

<±5 mmHg vs. reference

(meets ISO standard)

Device Accuracy
(Mean ± SD)

CER accepted with no technical file gaps

EU MDR Audit Outcome

89/100 (Excellent)

High inter-rater reliability (ICC > 0.95)

Outcomes

Subjects Enrolled 112

Device Accuracy (Mean ± SD) <±5 mmHg vs. reference (meets ISO standard)

Repeatability High inter-rater reliability (ICC > 0.95)

EU MDR Audit Outcome CER accepted with no technical file gaps

Connectivity/Data Sync Errors <1%

Time to 510(k) Submission Within 3 weeks post DB lock

High inter-rater reliability (ICC > 0.95) 89/100 (Excellent)

Client Testimonial

VP of Product Development
Digital Health Company

“Clinvigilant delivered a seamless and scientifically robust study that made our FDA and MDR pathways smooth. Their attention to regulatory detail and real-world data capture was critical.”

Results?

With Clinvigilant’s clinical and regulatory expertise, the sponsor was able to confidently validate and submit a next-generation blood pressure monitoring system to global regulators — supported by a high-quality dataset, integrated device and app analytics, and comprehensive clinical reporting.

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