Compliance built-in

Our products and quality management system are developed, tested, and certified according to highest industry standards. Our experience as medical device manufacturer ensures the highest level of compliance, safety, data protection, and performance.

HIPAA

HIPAA compliance ensures the protection of patient health information through secure handling, storage, and transmission practices.

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HIPAA compliance ensures the protection of patient health information through secure handling, storage, and transmission practices.

FDA

The FDA (Food and Drug Administration) regulates food, drugs, medical devices, and cosmetics to ensure public safety and efficacy.

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ISO

ISO (International Organization for Standardization) develops and publishes international standards to ensure quality, safety, and efficiency across various industries.

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Certified to the highest standards

Our products and quality management system are developed, tested, and certified according to highest industry standards. Our experience as medical device manufacturer ensures the highest level of compliance, safety, data protection, and performance.

ISO13485

A quality management standard for medical devices. It outlines requirements for a QMS, emphasizing risk management, documentation, and continual improvement to ensure compliance with regulatory and customer needs.

CE(MDD)

The CE Marking for Medical Devices Directive (MDD) ensures products meet EU safety standards. It requires rigorous testing, documentation, and conformity assessment to ensure the safety and efficacy of medical devices.

IEC60601-1

An international standard governing the safety and essential performance of medical electrical equipment. It mandates rigorous testing and risk assessment to ensure devices meet stringent safety requirements for patient and operator protection.

IEC60601-1-2

An international standard specifying electromagnetic compatibility requirements for medical electrical equipment. It ensures devices operate safely in environments with electromagnetic disturbances, minimizing risks to patients and operators.

IEC62304

A standard for medical device software lifecycle processes. It outlines requirements for development, maintenance, and risk management to ensure the safety and effectiveness of medical software throughout its lifecycle.

IEC62366

A standard for applying usability engineering to medical devices. It guides the design process to optimize usability, ensuring devices are intuitive and safe for users, ultimately enhancing patient care and safety.

IEC14971

A standard for risk management in medical devices. It outlines processes to identify, evaluate, and mitigate risks throughout the product lifecycle, ensuring devices are safe for patients, operators, and the environment.

IEC60601-2-25

A standard focusing on the safety and essential performance of electrocardiograph (ECG) equipment. It defines specific requirements for the design and operation of ECG devices, ensuring accuracy and patient safety during diagnostic procedures.

 

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