Blood Pressure Validation Testing Lab: Accurate. Regulator-Ready. Trusted.

At Parameters Research Laboratory (PRL), we specialize in providing regulatory-grade validation for blood pressure monitoring devices, including both traditional cuff-based devices and emerging cuffless wearables. As a dedicated blood pressure validation testing lab, we deliver the scientific rigor and regulatory alignment developers need to succeed in FDA and CE mark submissions. 

Why Blood Pressure Validation Matters 

Accuracy in blood pressure monitoring is critical for clinical decision-making, and regulators require devices to undergo rigorous testing before approval. PRL ensures devices are tested against international standards, helping you avoid costly delays and submission rejections. 

We conduct studies in compliance with: 

• ISO 81060-2 (non-invasive sphygmomanometers, cuff based oscillometry) 

• ISO 81060-7 (cuffless blood pressure measurement) 

• ISO 14155 and good clinical practice (GCP) 

Why Choose PRL as Your Validation Testing Lab? 

Regulatory-Grade Expertise 

Our studies are designed to produce regulator-ready clinical endpoints that align with FDA and notified body expectations, minimizing risk of submission delays. 

Inclusive Recruitment 

PRL’s recruitment strategy ensures compliance with strict requirements for age, sex, and arm circumference distribution. We are also leaders in inclusive participant recruitment, supporting equitable validation across diverse populations. 

Support for Emerging Wearables 

With experience in ISO 81060-7 studies, PRL is uniquely positioned to validate new cuffless and wearable devices, ensuring accuracy across blood pressure demographics. 

Risk Mitigation and Trial Rescue 

We anticipate and address risks proactively—whether through protocol optimization, CRO transparency, or a risk-based monitoring plan when trials face challenges. 

Gold-Standard Reference Methods 

At PRL, validation accuracy is paramount. For intermittent noninvasive blood pressure device studies, we employ dual-listener auscultation as the reference method of choice, ensuring every reading is verified independently by two trained observers using a double stethoscope.  

We also offer validation against an intra-arterial line, the gold standard for continuous blood pressure measurement. By leveraging invasive arterial reference methods where appropriate, we provide the highest level of accuracy and confidence in device performance across a full range of clinical settings. 

Comprehensive CRO Services 

Beyond being a blood pressure validation testing lab, PRL offers: 

• Clinical trial protocol development 

• FDA Q-Sub and 510(k) strategy assistance 

• CE mark regulatory support 

• Multi-site clinical research management 

• Comprehensive study monitoring  

• Testing that meets AMA’s Validated Device Listing (VDL) requirements 

• Transparent communication at every stage 

Partner with PRL 

Choosing the right blood pressure validation testing lab is essential for regulatory success. With PRL, you gain a trusted partner committed to precision, inclusivity, and regulatory alignment — so you can bring safe, effective, and innovative devices to market with confidence. 

Ready to Validate Your Device? 

📞 Contact PRL today to discuss your blood pressure validation study needs and take the first step toward regulatory approval. 

*See Disclaimer regarding AI-generated content