Medical Device Malfunction Report｜Safety Information Services｜General Incorporated Foundation International Medical Information Center (IMIC)

Medical Device Malfunction Report

Attentive Support by Highly Experienced Staff

Our highly experienced staff delivers comprehensive operational support—covering everything from the English translation of overseas medical device case reports to the creation of regulatory malfunction report XML files.
We also accept partial translation requests, such as translating only the malfunction descriptions or investigational findings.

ABOUT

Overview of Medical Device Malfunction Report

Extensive Track Record and Reliable Quality

Our extensive experience in medical device translation and safety information gathering is directly reflected in the high quality of our malfunction report preparation services. We have a proven track record of handling cases centered on general surgery, cardiovascular, and neurovascular fields, covering both therapeutic and preventive sectors. Regardless of the therapeutic area or field, we will tailor each report to perfectly align with your specific needs and requirements.

We offer a wide range of support services tailored to your needs.
You can choose from the following two service options:

Partial Translation or Summarization Support (English to Japanese).
We partially translate or summarize malfunction details and investigation results according to your company’s specific drafting rules, delivering the final output in your preferred file format.
Full-Service Malfunction Report Draft Compilation (English to Japanese).
We translate and summarize content from your preferred source file formats—such as Excel, Word, or PDF—to prepare a comprehensive draft of the malfunction report containing all necessary information. The final deliverable will be provided in your designated file format, including XML.

*Even for clients outsourcing for the first time, we provide full support in establishing your malfunction reporting workflows.
We can assist in creating customized terminology glossaries and templates tailored to your specific products. Furthermore, we can help establish your end-to-end operational process—such as a workflow involving an initial draft delivery, customer review, and subsequent final revision delivery (additional fees may apply).

Long-term partnership enables seamless standardization of report content.

Any feedback we receive from you regarding preferred terminology or content adjustments will be strictly applied to all subsequent translations. By partnering with us on an ongoing basis, we can further standardize and refine the report content to perfectly match your specific requirements.

If you are considering implementing our service, we can offer a trial opportunity.
Please feel free to contact us.

Click here for quotes and inquiries

FLOW

Implementation Flow for Medical Device Malfunction Report

1 Request for a quote

Please contact our sales department first. Our representative will assist you.
2 Consultation (Online or In-Person)

We will review the information entered for each section and the delivery schedule.
3 Quote preparation

We will determine the scope of services based on the details discussed during our consultation and prepare a quote.
4 Service order

We will start operations according to your preferred schedule.
5 Review and Optimization of Operations

We will continue to optimize our workflow and operations based on your feedback even after the project begins.

Any feedback we receive from you regarding specific terminology or the content of reports after the start of the operation will be reflected in future translations, allowing us to standardize the report format to better meet your requirements.

FAQ

FAQs for Medical Device Malfunction Report

Do the contents of the medical device malfunction reports comply with PMDA requirements?

We always prepare reports in accordance with the latest edition of the “Guidelines for Medical Device Malfunction Reports.”

What is the turnaround time for this service? Is rush service available?

Our standard turnaround time is 5 to 10 business days, counting the day of your request as Day 0. Urgent requests can also be accommodated for an additional fee. Since your preferred deadline may vary depending on whether it is a 15-day or 30-day regulatory report, we will consult with you in advance to adjust and establish the optimal delivery cycle.

Do you accommodate requests for consistent terminology and phrasing, as well as the use of standard templates?

Yes, we can accommodate such requests. If your company has its own glossary or list of preferred terms, please provide it to us in advance.

What should we do if we want the report to be prepared with a deep understanding of our product?

Providing us with relevant materials in advance (such as package inserts, product specifications, samples of past reports, and product demonstration videos) and explaining the product, as well as any malfunctions or adverse events, during consultations will help us better understand the product and enable us to submit more accurate reports.

Can we request domestic cases as well?

We can also prepare reports for domestic cases. We follow the same workflow and maintain the same high standards as we do for reports on overseas cases. Furthermore, we can accommodate various forms, including the Form 8, for both domestic and overseas cases. Please feel free to contact us for a consultation.

Click here to contact us