About VistaMed Masimo Technologies | Medical Device Innovation Since 2009

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Certificates and Honors

Certificates and Honors

Regulatory Certifications:

  • ISO 13485:2016 Quality Management System (BSI Certificate No. FS 738429)
  • FDA 510(k) Clearance for IntelliScan AI Diagnostic System (K243456)
  • CE Mark under EU MDR 2017/745 (Notified Body: TÜV SÜD NB 0123)
  • NMPA Class III Medical Device Registration (No. 20253060089)
  • GB 9706.1-2020 National Standard Compliance Certificate
  • IEC 62304 Medical Device Software Lifecycle Certification
  • HIPAA & GDPR Compliant Healthcare Data Processing Certification

Industry Recognitions:

  • Frost & Sullivan 2024 Asia-Pacific Medical Imaging Innovation Award
  • MedTech Breakthrough Award: Best AI Diagnostic Solution (2024)
  • Red Dot Design Award: Medical Equipment Category (IntelliScan Series, 2023)
  • China Medical Device Innovation Enterprise Top 10 (Ministry of Industry & IT, 2023)
  • European Healthcare Technology Sustainability Award (EHMA, 2024)

the Honor we received

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About us

About VistaMed Masimo Technologies | Medical Device Innovation Since 2009

Founded in 2009, VistaMed Technologies specializes in providing high-end medical solutions for chronic disease monitoring devices. Headquartered on the 20th floor of Huarun Building in Nanshan District, Shenzhen City, Guangdong Province, we are dedicated to serving over 500 healthcare facilities nationwide. Our 20,000 sq ft manufacturing facility is ISO 13485 certified, and all our products have received FDA 510(k) clearance. At VistaMed, we value Quality First, Customer Focus, Innovation, Integrity, and Compliance, aiming to empower healthcare providers with accurate, reliable, and cost-effective chronic disease monitoring solutions to improve patient outcomes.

Team Of Highly Skilled

Dr. Evelyn Reed
Dr. Evelyn Reed
MD Role: Lead Medical Content Reviewer & Clinical Advisor (International)
With over a decade of experience in medical communications, she specializes in translating complex clinical data and technical information into clear, accurate, and actionable insights for healthcare professionals
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Dr. Wei Li (李伟)
Dr. Wei Li (李伟)
PhD Role: Chief Technology Officer & Head of R&D (Shenzhen, China)
With over 20 years of experience in biomedical engineering, Dr. Li is the lead inventor on a significant portion of VistaMed's 87 granted patents. His leadership was instrumental in the development of the IntelliScan AI Diagnostic System, which earned both the MedTech Breakthrough Award (2024) and the Red Dot Design Award (2023).
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Dr. Michael Bauer, PhD
Dr. Michael Bauer, PhD
Head of Clinical Research (International)
With a PhD in Clinical Physiology and extensive experience designing trials for medical technology, he is responsible for the studies that validate our products against the most stringent international standards, including ISO 81060-2 for blood pressure monitors and AAMI/ESH/ISO protocols
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Fang Chen (陈芳)
Fang Chen (陈芳)
Director of Global Product Strategy & Customer Insights (Shenzhen, China)
With 15 years of experience in MedTech product management, she has gathered deep, first-hand insights from our 500+ client healthcare facilities across Asia, Europe, and the Middle East
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Dr. Evelyn Reed
Dr. Evelyn Reed
MD Role: Lead Medical Content Reviewer & Clinical Advisor (International)
Dr. Wei Li (李伟)
Dr. Wei Li (李伟)
PhD Role: Chief Technology Officer & Head of R&D (Shenzhen, China)
Dr. Michael Bauer, PhD
Dr. Michael Bauer, PhD
Head of Clinical Research (International)
Fang Chen (陈芳)
Fang Chen (陈芳)
Director of Global Product Strategy & Customer Insights (Shenzhen, China)

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About VistaMed Masimo Technologies | Medical Device Innovation Since 2009