Importance of Simultaneous Releases
Medical Devices take many years to get developed, debugged, perfected and approved by regulatory bodies around the world. Once approved, Medical Device manufacturers and their investors seek to capitalize on their investment by expediently entering as many markets as they can!
Delays not only in the initial localization process, but also in follow up product updates have to be minimized, making simultaneous releases a desired goal.
Most projects are guided by ongoing release cycles of source documents, or the launch of a new instrument. Typically, the release is targeted to be nearly simultaneous across all languages. Unfortunately changes to the source language can still be requested until the last minute of the release cycle creating possible havoc with translation teams!
Strong coordination between your company and the translation agency is necessary. The communication of solid freeze schedule or drop-dead dates indicating when updates to the source files would impact the release date is an essential part of the service your translation partner brings.
Factoring in local reviews and local approval cycles are very essential. They are typically under your control but should be firmly enforced as they do factor into the international release schedule and the completion of localized products.
This is why the use of a Translation Management System that provides transparency to the whole process and to all stakeholders is fundamental.
Must Have Translation Services To Enable Simultaneous Releases of Medical Devices
Simultaneous releases can only be delivered if the following services are provided and executed from within the translation management system:
- Support of all required languages with medical translation subject matter experts
- Ability to optimize reviews online with in-country staff or by secondary translators
- Ability to perform software localization
- Creation and maintenance of an accurate Translation Memory for each language
- Professional Layout or Desktop Publishing in all standard file formats for all languages
- Ability to perform blind Back-Translation when needed, and
- Transparent 24/7 access to the translation assets and project tracking to allow necessary last minute updates.
GlobalVision is also ISO 9001 certified and would gladly provide a free Certificate of Accuracy for your 21 CFR Part 11 compliant records.
Would Simultaneous Translation of your Medical Devices Help your Bottom Line? Why take unnecessary risks? Read our white paper 5 Case Studies in Medical Translation and Localization, or register to attend the 15 minute free webinar.
You may also contact GlobalVision for a complementary professional consultation!Please Share!