Statistically speaking, almost none of us have escaped a visit to the doctor in this life. Whether it was for a cold, a pandemic, or other more detailed investigations, we all visited a medical or radiology office one time, or a hospital. There, people who have dedicated their lives to saving their fellow humans work with medical devices every day.
For a medical device, there are several types of documents that beneficiaries, whether doctors or patients, must receive translated into their language. The Medical Division of our agency works with seven main categories of documents that need to be translated for these devices. We do this for the proper understanding and subsequent use of these devices, whether we are talking about a syringe, a blood pressure monitor, or an MRI.
Instructions for Use (IFU)
The Instructions for Use (IFU) are essential documents that describe the correct way to use a medical device. They also discuss installation procedures and precautionary measures.
Target Audience: They are intended for end-users, including medical staff and, in some cases, patients who use the device independently.
Applicability: All types of medical devices, from simple surgical instruments to complex diagnostic and treatment equipment, come with a set of instructions.
User’s Manual
The user’s manual provides detailed instructions on using the device, including settings, daily operation, routine maintenance, and safety measures. It’s that manual you leave in the box when you pull out the vacuum cleaner, but for a new sterilizer, for example, it will prove extremely useful for sure.
Target Audience: It is intended for end-users, i.e., doctors, nurses, technicians, and patients, depending on the device.
Applicability: It is used for a wide range of medical devices, including patient monitors, ventilators, and other vital support equipment, MRIs, CTs, and so on.
Labeling and Packaging Content
Labels and packaging include essential information about the medical device. They refer to the product name, manufacturer, storage instructions, and expiration date. These are the first pieces of information related to the device that the user encounters after purchase.
Target Audience: It is primarily intended for end-users, distributors, and regulatory authorities.
Applicability: They are used for all medical devices, from consumables and accessories to complex equipment.
Technical Documents
Technical documentation includes specifications, diagrams, and repair and maintenance procedures for medical devices. It is crucial for doctors, but especially for those who deal with the maintenance or repair of these devices.
Target Audience: It is intended for technicians, engineers, and service personnel.
Applicability: It is used for complex devices that require regular maintenance and repairs. Examples would be medical imaging equipment and laboratory apparatus.
Clinical Trials and Research
Clinical trial and research documents present data on the efficacy and safety of a new treatment/medical device. Practically, these represent the scientific basis that demonstrates that the respective product is safe to use and beneficial for consultation, diagnosis, or treatment of the patient.
Target Audience: It is intended for regulatory authorities, researchers, and healthcare professionals.
Applicability: For study drugs and newly appeared or modified devices that require clinical validation before receiving marketing authorization. Regardless of the nature of the treatment/device, they help complete the informational framework to assist doctors, scientists, and, at the same time, patients.
Regulatory Documentation
Regulatory documentation includes approval applications, conformity assessment reports, and declarations of conformity. It is the unseen but very important part of the process of bringing the medical device from a foreign country to us or placing it on the market in the country where it was created.
Target Audience: It is intended for regulatory authorities and certification bodies.
Applicability: It is used for all medical equipment that requires approvals and certifications before being introduced to the market.
Marketing Materials
Marketing materials include brochures, flyers, websites, and other promotional materials that present the benefits and utilities of a particular medical device. These are among the most demanding types of translations. Why? Because they must be compliant with the original, present the scientific basis of the product in question, and sound attractive to be useful in promoting it, meaning they must go through a marketing filter.
Target Audience: It is intended for healthcare professionals and the general public.
Applicability: They are used for all medical devices, aiming to inform and attract potential users and buyers, especially in the case of new devices that can be widely used by doctors and, especially, directly by patients.
What we pay attention to when translating documents for medical equipment
When translating documents related to medical products, using the correct terminology and ensuring terminological consistency is crucial. It is essential to use the correct/approved terms and maintain the same terminology throughout the document to avoid confusion and errors. Additionally, we need to adapt the language according to the target audience, whether they are specialists in the field, such as doctors, or the general public.
”The appearance of the document and layout also play an important role, as it is necessary to consider the graphic part (desktop publishing) to ensure a clear and professional presentation. Localization of the document is vital to ensure it is culturally and linguistically appropriate for the target market.
In the case of marketing documents, expression and tone of the message are essential, as it is important to identify the target audience to appropriately adapt the communication method. Each country has its specifics, and understanding the client’s wishes regarding the tone of the message – formal (if addressing specialized personnel) or informal (if addressing the general public) – is important” – Alexia Pintea, project manager of the Medical Division at Swiss Solutions.
Also, if the project includes a motto, it is necessary to discuss with the client to understand what they want to convey through it once translated or, if applicable, to respect an already established version. Regarding clinical studies, translating the title and content must be done with precision while maintaining the accuracy and original meaning, or if an official translation already exists, it must be preserved.
If you need to translate one (or more) of the seven types of documents described here, write us an email and we will help you right away.
