Meteuropescan is your trusted PARTNER

for inspection of your medical equipment.

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About Us

Meteuropescan is an accredited and authorize entity recognized by the Romanian National Accreditation Authority, adhering to stringent standards of quality and reliability, including SR EN ISO/CEI 17020: 2012, SR EN ISO 9001: 2015, SR EN ISO 14001: 2015, SR ISO 45001: 2018. We are acredited to perform hoigh-quality verification and inspaction of measuring medical devices, we commit to upholding the highest levels of precision and care in our services.

Trusted and certified partner
Professional verification and certification
Security, reliability, excellence

At the heart of everything we do are our core values and a dedicated mission to provide the utmost in reliable services for the verification of medical devices. Our primary aim is to enhance patient healthcare, all while embodying our vision to become the most trusted partner for our valued customers.

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Why choose Meteuropescan verification services

To consistently deliver top-notch services, we systematically identify essential processes and allocate the necessary resources to manage our business with reliability and success. We meticulously document and control all pertinent activities, ensuring thorough planning and provision of resources, as well as clear assignment of responsibilities and authorities. The services offered by Meteuropescan Romania are committed to always meeting the satisfaction of our clients and complying with relevant authorities. In cases where expectations are not met, a comprehensive review and improvement process is initiated.

01 Service Dependability

At our company, every operation adheres to procedures aligned with international standards for regulatory bodies SR EN ISO/CEI 17020:2012. These standards guarantee that our activities are meticulously documented, tests conducted are reliable, and decisions made are both accurate and trustworthy. This commitment ensures that we can consistently provide dependable services and accurate measurement results at any given time.
02 Cutting-edge Equipment

In delivering services to our clients, we boast fitting facilities and state-of-the-art equipment essential for conducting verification activities. Regular maintenance and calibration procedures are rigorously carried out to guarantee precision and alignment with the intended use, adhering to international standards and SI units.
03 Client-Centric Approach

As we conduct our operations in alignment with the needs and expectations of stakeholders and clients, our dedication lies in cultivating enduring relationships. We are committed and responsible for fostering these connections to ensure mutual benefits and satisfaction.

You are responsible for your Patiences

Several studies have been conducted to evaluate the primary factors contributing to patient harm associated with medical devices. These factors not only raise concerns about potential misdiagnoses but also highlight the risk of improper treatment or immediate harm

Out-of-Calibration Measuring Instruments47%

Device Malfunction or Failure23%

Inadequate Monitoring or Supervision15%

User Error or Inadequate Training15%

It's crucial for healthcare providers, manufacturers, and regulatory bodies to address these factors through continuous improvement, rigorous testing, and comprehensive training to enhance patient safety in the use of medical devices.

Services

The measuring devices integrated into medical equipment and routinely utilized in the healthcare system pose inherent safety risks. Beyond the expertise of healthcare professionals, the verification of these devices is crucial. This is because the measurements derived from these instruments play a pivotal role in the diagnosis, treatment, and monitoring of patients.

DEFIBRILLATORS

A defibrillator is an electrical apparatus designed to counteract sudden cardiac arrest by administering a regulated electric shock to the heart via the chest, aiming to reestablish normal heart activity. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within defibrillators must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-2-4:2012
SR EN 60601-1-12

DIALYSIS

A dialysis device is an electric automatic device which is used for hemodialysis. Hemodialysis is a process that represents the exchange between the patient's blood and the electrolyte solution in which waste products are removed from the patient's blood and almost normal electrolyte balance is established. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within dialysis devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-2-24:2015
SR EN 60601-1-11:2015/A1:2021
SR EN 60601-2-16:2019

INFUSION AND PERFUSION

An infusion pump is a specialized medical electrical device engineered to control the flow of fluids entering a patient's body, operating under specific pressure generated by gravitational force. This device plays a crucial role in ensuring precise fluid delivery in medical treatments. Separately, a perfusion pump is another type of medical electrical device, distinctively designed to regulate the fluid flow into a patient, with the pressure being generated by the pump itself. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within infusion and perfusion devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-2-24:2015
SR EN 60601-1-11:2015/A1:2021
SR EN 60601-2-16:2019

ULTRASOUND DEVICES

An ultrasonic physiotherapy device is an advanced electrical apparatus that utilizes a probe to produce an ultrasound signal. This signal is specifically generated for therapeutic treatment purposes, employing sound waves to effectively target areas requiring medical attention. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within ultrasonic physiotherapy devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-2-5:2016
SR EN 60601-1-11:2015/A1:2021

ELECTROCARDIOGRAPH

An electrocardiograph (ECG) is an electrical device that records and displays electrical signals of heart's potential from the surface of the body as a function of time. The record of cardiac activity is called an electrocardiogram. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within ECG devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-2-5:2016
SR EN 60601-1-11:2015/A1:2021

MULTIFUNCTIONAL DEVICES

A multifunctional device for patient monitoring is a modular or pre-configured device that includes more than one physiological monitoring unit. These units are designed to generate alarms and collect information from a patient in order to process that information for monitoring purposes. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within multifunctional devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN IEC 80601-2-49:2020
SR EN 60601-2-55:2015
SR EN 60601-2-69:2015
SR EN 60601-1-11:2015/A1:2021

VENTILATORS DEVICES

A ventilator is an automated electric apparatus equipped with an air supply connection for the patient. It functions to sustain respiratory activity or enhance the patient's breathing capability. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within ventilator devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-1-11:2015/A1:2021
SR EN 60601-1-55:2018
SR EN ISO 80601-2-67:2021
SR EN ISO 80601-2-72:2016

ANESTHESIOLOGICAL SYSTEMS

An anesthesiologic system is a precisely engineered arrangement that operates on continuous flow, volume, and pressure. Its design ensures the delivery of medical gases, blended with an exact concentration of anesthetic vapor (like sevorane), to the patient. This system is crafted to administer these mixtures at a safe pressure, volume, and flow, ensuring both accuracy and safety in anesthetic delivery. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within anesthesiologic systems must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-1-11:2015/A1:2021
SR EN 80601-2-13
SR EN 80601-2-56:2017
SR EN 80601-2-49:2020
SR EN 80601-2-12:2020

NEONATAL AND PEDIATRIC INCUBATORS

An incubator for newborns is a specialized medical electrical device featuring a compartment designed to control the environmental conditions surrounding a newborn. This control is primarily achieved through the use of heated air within the compartment. There are two types of incubators: stationary and transport. Transport incubators are uniquely equipped with both a compartment and a portable power source, facilitating the safe movement of newborns while maintaining optimal conditions. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within neonatal and pedriatic incubators must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-1-11:2015/A1:2021
SR EN IEC 60601-2-19:2021
SR EN IEC 60601-2-20:2020
SR EN IEC 60601-2-21:2021

MANOMETERS DEVICES

Blood pressure is the pressure in the arterial system of the human body which can be measured with a manometer for measuring blood pressure. Blood pressure measurement can be invasive or non-invasive (indirect blood pressure measurement without penetrating the artery). The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within manometer devices must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-2-11:2015
SR EN 60601-1-11:2015/A1:2021

HIGH FREQUENCY SURGICAL KNIVES

A high-frequency surgical knife is a medical electrical device equipped with the necessary tools for conducting surgical procedures. It performs functions like cutting or coagulating biological tissue through the use of high-frequency currents. Complementing this device, high-frequency surgical accessories are designed for managing, supplementing, and monitoring the high-frequency energy delivered to a patient during procedures involving a high-frequency surgical knife. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within high frequency surgical knives must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-1-11:2015/A1:2021
SR EN IEC 60601-2-2:2018
SR EN 60601-1-12

ELECTRICAL CIRCUITS

Electrical circuits in hospitals are intricately designed and critically important systems that ensure the safe, reliable, and efficient operation of various medical devices and hospital infrastructure. These circuits are not just ordinary electrical setups; they are engineered to meet stringent safety standards and to support the complex demands of medical care. The protocols for both regular and exceptional inspections, along with the standards that measuring instruments within the electrical systems must adhere to the below standards:

SR EN 60601-1:2007
SR EN 60601-1-11:2015/A1:2021
SR EN 60601-1-11:2015
SR EN 60601-1-12:2015

Call To Action

Ensuring the continuous calibration and optimal functioning of your medical equipment, you prioritize the well-being of your patients. In overcoming this challenge, we stand as your trusted partner, and our dedicated team is here to serve you with unwavering commitment.

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Our acreditations and certificates

Portfolio

Welcome to the Meteuropescan Medical Devices Inspection Portfolio!

DEFIBRILLATORS
DIALYSIS
INFUSION AND PERFUSION
ELECTROCARDIOGRAPH
ULTRASOUND DEVICES
MULTIFUNCTIONAL DEVICES
MANOMETERS
VENTILATORS
ANESTHESIOLOGICAL
Neonatal Incubators
HIGH FREQUENCY SURGICAL KNIVES