Manual Production

We deal with a wide range of medical devices in medical field, ranging from home medical devices (blood pressure monitors, etc.) to medical devices that require special knowledge and a higher level of safety, such as endoscopes and artificial hearts.
We support the risk management that is required for medical devices. We conduct risk assessment and risk analysis from the user's perspective and report the analysis results. We will provide feedback on residual risks to the design department for improving safety and protection and reflect them in the manuals and labels.

We will objectively evaluate the usability and compliance status with laws and standards by comparing and analyzing the IFUs of your product with that of your competitors' products. You can improve your IFUs based on the results of the evaluation and make them stand out by producing IFUs that are superior to those of competitors' in the industry.

High quality translations through the experience in creating IFUs and package inserts for medical devices

Our translators specialize in medical devices and can translate a wide range of medical documents for pharmaceutical and medical device companies. Since the top priority in the translation of medical and pharmaceutical documents is accuracy, we have established a thorough quality check system by native speakers. We will provide translations taking into account the terminology for regulatory information (laws and regulations and standards, etc.) related to your medical devices. We also provide full support for Japanese companies entering the overseas market and for foreign companies entering the Japanese market.

By assessing the risk of potential nature of danger (mechanical, electrical, thermal, chemical, etc.) and foreseeable misuse in each process of a product life cycle, we will propose risk assessment and risk reduction as prescribed by international safety standards such as ISO12100 and ISO14971.

We will objectively evaluate the product safety and compliance status with laws and standards by comparing and analyzing the manuals of your company with the manuals of your competitors' products. You can improve your manuals based on the results of the evaluation and make them stand out by producing manuals that are superior to those of other companies in the industry.

High-quality translations through the experience in creating various manuals of industrial machinery

We provide high-quality translation services specializing in industrial machinery, leveraging our translation experience in the industrial machinery field. We can also provide multilingual translation and DTP editing in compliance with laws and standards for industrial machinery.

Inquiries to the call center or sales department are where the real voices of users, such as complaints and various questions, are collected. We will identify the usability problems of the product, shortcomings of the manual, and potential risks by analyzing the data and propose improvements.

We offer various tests to verify whether the contents of manuals and video manuals, etc., are useful and suited for the intended purpose, while operating the actual product. We can also examine your existing contents produced elsewhere.

High-quality translations through the experience of producing instruction manuals for consumer electronics

Based on our translation experience in the field of consumer electronics, we will provide bilingual translations not only converting one language to another, but including an awareness of the ""differences"" in ideas and values based on history, culture, etc. We can also provide multilingual translation and DTP editing in compliance with laws and standards of the consumer electronics field.

By assisting you from the process analysis stage of your current operations, we can help you to not only create operation flows but also review them and identify risks. We can propose a operations manual that is specific to your system.

Preparing an operations manual ensures that anyone can execute the work and the manual will also serve as a bible during personnel changes or when emergency response is required.

Provide stable services and operations

The manual helps unify work methods without relying on the skills of each personnel. This will ensure providing services and operations at a certain quality level.

Operation reviews

By conducting operation analysis during the creation stage of the operations manual, you can identify the operations to improve. We not only eliminate unreasonable, pointless and inconsistent work but also identify hidden risks in the operations at the process analysis stage.

Building common assets

Information sharing and skill transfers can be made easier by making individual assets such as techniques and know-how tangible.

Application to new employee training

Training costs can be reduced and training period shortened by using operation manuals that are based on actual business practices for training new employees.

Clarification of responsibility and authority

Preparing operation manuals clarifies the role and code of conduct of each employee, leading to higher levels of operations and service quality.