Medical Safety & Compliance Solution

Ensuring the Reliability of Medical Devices to Safeguard Healthcare Professionals and Patients

In the medical industry, equipment must not only be efficient and stable but also meet strict international safety regulations to ensure patient and healthcare safety. With the rise of smart healthcare and telemedicine, manufacturers face the dual challenge of achieving both regulatory compliance and innovative applications.

A medical safety regulation needs to meet the electrical safety standards of various countries before medical products are sold worldwide. This mandatory testing procedure can ensure that medical products will not function abnormally to affect other medical equipment or be affected by other equipment during use. It can avoid misjudgment and harm to patients and patients.

Medical Regulation

Medical safety regulations are different from information security regulations. They have more stringent testing requirements to resist environmental impact and avoid affecting other medical devices, such as system insulation, external labeling, risk management, and electronic compatibility.

System insulation

External labeling

Risk management

Electronic compatibility

Portwell’s Medical Applications

Portwell provides a wide range of medical solutions, including:

Medical Ultrasound

Medical Ultrasound

Physiological Measurement Systems

Patient Monitoring Systems

Patient Monitoring Systems

Information Management Systems

Information Management Systems

Medical Self-Service Kiosks

Medical Self-Service Kiosks

Telemedicine

Telemedicine

All these applications are powered by Edge AI technology, enhancing diagnostic accuracy and clinical efficiency

Compliance & Validation

Our medical products comply with IEC 60601-1 electrical safety standards and ISO 13485 medical device quality management systems. With comprehensive in-house testing — including thermal analysis, EMI, ESD, vibration, and HALT — we ensure products remain safe and reliable in the most demanding environments.

(IEC EN UL) 60601-1 3rd

Classification, Identification, Marking And Documents, Power Input, Limitation Of Voltage and Energy, Enclosures And Protective Covers, Mechanical Strength-Stability In Normal Use, Abnormal Operation And Fault Conditions… Basic safety and functional tests (leakage current test, grounding Impedance test, insulation withstand voltage test, working temperature test, waterproof test, flame resistance test, electromagnetic compatibility test, biocompatibility test), risk assessment report, feasibility assessment report

(IEC EN) 60601-1-2 4th :

Electromagnetic Interference (EMI), Electrostatic Discharge (ESD), Radiated Susceptibility (RS), Surge (Surge), Electrical Fast Transient (EFT), Power Frequency Magnetic Field (PFMF), Conducted Susceptibility(CS), Voltage dips, short interruptions and voltage variations immunity (DIP).

Reliability test:

Temperature and Humidity Test (IEC 60068-2-1, 60068-2-14, 60068-2-78), IP Rating Test (IEC 60529, 60598), Vibration Test (IEC 60068-2-64), Drop Test (ISO 2248) ), Impact test (IEC60068-2-27).

Key Advantages

  • High-Reliability Design: Isolated LAN, COM, and USB interfaces minimize EMI and secure medical data transmission.

  • Smart Applications: AI algorithms accelerate diagnostics and support critical decision-making.

  • Remote Management: With RPET Remote Engineering Toolkits, manufacturers gain real-time monitoring and analytics to ensure system stability.

Why Partner with Portwell

Global Expertise in Healthcare Solution

As a trusted provider in medical and healthcare computing, Portwell leverages decades of expertise in industrial-grade design and regulatory compliance. Our commitment is to deliver reliable, safe, and innovative solutions that empower medical device manufacturers, hospitals, and system integrators to build scalable and future-ready healthcare applications.

Broad Medical Product Portfolio

Portwell offers an extensive range of healthcare-focused products, including medical-grade embedded boards, medical panel PCs, patient monitoring systems, and AI-enabled diagnostic platforms. With designs compliant with IEC 60601-1 and ISO 13485, our solutions ensure safety, performance, and long-term reliability for diverse medical environments.

End-to-End Healthcare Support Services

Beyond hardware, Portwell provides comprehensive DMS and EMS services tailored for healthcare. From design, prototyping, certification, and production to testing and logistics, our integrated services help customers navigate strict medical regulations, accelerate time-to-market, and achieve sustainable growth in the evolving healthcare industry.

Choosing Portwell means more than hardware — it’s about gaining a trusted partner with 30+ years of industrial computing expertise and strong medical compliance knowledge. We help manufacturers shorten certification cycles, accelerate time-to-market, and enhance overall healthcare quality.

Application Note

Medical-Grade Computers

MEDS-2000

Medical Box PC

The MEDS Series offers a comprehensive range of medical-grade computing solutions, from compact NUC-sized systems to high-performance hospital data center computers. Designed for healthcare environments, these systems feature silent operation, rich I/O options, AI edge processing, and compliance with medical standards. Ideal for applications such as medical imaging, hospital information systems, AI-assisted diagnostics, and edge AI in healthcare.

Medical Information Terminal

Medical Information Terminal

The Medical Information Terminal series delivers high-performance medical panel PCs and displays designed for hospitals, clinics, and healthcare facilities. With antimicrobial housing, easy-to-clean surfaces, and compliance with medical safety standards, these systems are ideal for patient data management, medical imaging, point-of-care applications, and operating room environments. Available in various screen sizes and touch options to meet diverse clinical needs.

Medical Grade Motherboards

Isolated Board

The Isolated Board series features medical-grade Mini-ITX motherboards powered by Intel® 10th Gen Core™ processors. Designed for high-performance computing in medical devices, these boards offer low-profile designs, advanced I/O connectivity, and compliance with medical safety standards. Ideal for applications such as medical imaging, diagnostics, and patient monitoring systems.