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The official Healthcare Translations logo, powered by Australis Localization.
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Solutions for Medical Device Firms

A complete list of our translation solutions specifically designed for Medical Device Firms

Solutions for Medical Device Firms

A complete list of our translation solutions specifically designed for Medical Device Firms
A doctor measures a patient's blood pressure using a sphygmomanometer in a clinical setting.

1. Instructions for Use (IFU)

These documents provide detailed steps on how to correctly use a medical device, including setup, operation, and maintenance.

Accurate translation ensure safe usage by healthcare professionals and patients in different countries.

Quote here
A doctor measures a patient's blood pressure using a sphygmomanometer in a clinical setting.

1. Instructions for Use (IFU)

These documents provide detailed steps on how to correctly use a medical device, including setup, operation, and maintenance.

Accurate translation ensure safe usage by healthcare professionals and patients in different countries.

Quote here

2. Technical Manuals and User Guides

These include more in-depth technical content than IFUs, often aimed at clinical engineers or technicians.

Precise translation is needed to support correct installation, troubleshooting, and repairs.

Quote here
A woman in a surgical gown is focused on using a computer in a clinical setting.
A woman in a surgical gown is focused on using a computer in a clinical setting.

2. Technical Manuals and User Guides

These include more in-depth technical content than IFUs, often aimed at clinical engineers or technicians.

Precise translation is needed to support correct installation, troubleshooting, and repairs.

Quote here
A person in a hospital room interacting with an electronic monitor, surrounded by medical equipment and soft lighting.

3. Regulatory Submissions and Technical Files

These are comprehensive documents submitted to regulatory agencies (such as the FDA, MDR/IVDR authorities) and include risk assessments, design specifications, and testing data.

Translations must meet the standards of each region’s regulatory body.

Quote here
A person in a hospital room interacting with an electronic monitor, surrounded by medical equipment and soft lighting.

3. Regulatory Submissions and Technical Files

These are comprehensive documents submitted to regulatory agencies (such as the FDA, MDR/IVDR authorities) and include risk assessments, design specifications, and testing data.

Translations must meet the standards of each region’s regulatory body.

Quote here

4. Clinical Evaluation Reports (CERs)

These reports assess clinical data to confirm the safety and performance of a device.

Translation supports international review and approval, especially under international guidelines.

Quote here
A woman lies on an MRI machine, preparing for a medical imaging procedure in a clinical setting.
A woman lies on an MRI machine, preparing for a medical imaging procedure in a clinical setting.

4. Clinical Evaluation Reports (CERs)

These reports assess clinical data to confirm the safety and performance of a device.

Translation supports international review and approval, especially under international guidelines.

Quote here
A hospital room featuring medical equipment, including a bed, monitors, and various tools for patient care.

5. Risk Management Documents

Includes risk analyses, mitigation strategies, and post-market surveillance plans.

Accurate translations ensure compliance with international safety requirements.

Quote here
A hospital room featuring medical equipment, including a bed, monitors, and various tools for patient care.

5. Risk Management Documents

Includes risk analyses, mitigation strategies, and post-market surveillance plans.

Accurate translations ensure compliance with international safety requirements.

Quote here
Contact the Healthcare Translations team now.
Complete the following form with the details of your project; we will respond within 24 hours with clear and straightforward answers.

    Contact the Healthcare Translations team now.
    Complete the following form with the details of your project; we will respond within 24 hours with clear and straightforward answers.

      The official Healthcare Translations logo, in a white monochromatic style, powered by Australis Localization.
      To schedule an appointment with one of our specialists, please call:
      • Healthcare Translations © 2025 All Rights Reserved

      Our translation and localization services designed for the diverse sectors of the healthcare industry.

      Learn about our expertise, processes, quality assurance methods, and operational protocols.

      Our collection of downloadable documents and articles that enhance our translation service offerings.

      Our full range of language services available for any project within the healthcare sector.

      Request a quote with us. We respond in less than 24 hours.

      Edit Template
      The official Healthcare Translations logo, in a white monochromatic style, powered by Australis Localization.
      Our translation and localization services designed for the diverse sectors of the healthcare industry.
      Learn about our expertise, processes, quality assurance methods, and operational protocols.
      Our collection of downloadable documents and articles that enhance our translation service offerings.
      Our full range of language services available for any project within the healthcare sector.
      Request a quote with us. We respond in less than 24 hours.
      To schedule an appointment with one of our specialists, please call:
      • Healthcare Translations © 2025 All Rights Reserved
      Edit Template