Customers: Medical Validation
Tek solution speeds engineering releases and maintains strict quality compliance for leading Medical Imaging client
The Client
This Tek client is a world-renowned leader in medical and security imaging, designing and manufacturing complex systems for international OEMs and strategic partners. Many of its clients are Fortune Global 500 companies who market these systems under their own names.
The Challenge
Many of this client's products are used in high-risk medical environments where there is no room for error. Therefore, the company is committed to infallible quality in both its products and its documentation. For this reason, the client chose to handle its translation validation activities in-house for many years, selecting its own subject matter experts.
The drawback to this hands-on system was that busy country managers or product managers were often responsible for the validations, slowing the process and preventing the company from meeting its market deadlines. In addition, the company often faced difficulties finding in-country technical specialists in certain languages and for certain products. Finally, there was no standard process in place for the validators to mark their changes to the translated files, which meant that the insertion of these changes was timeconsuming, error-prone and costly.
This client needed a new, standardized, consistent solution that would deliver high-quality documentation, yet reduce the time and costs of validation. It turned to its globalization partner, Tek Translation International, to provide the options.
The Solution
This client's initial project with Tek involved validation of an operator's manual for a new, compact ante partum fetal monitor which provides the maternal blood pressure and heart rate measurements that are critical for managing the birthing process. The company wanted impeccable validation, conducted by professionals, with a clear paper trail in order to comply with regulatory requirements.
- Tek proposed a solution that would meet all of the client's goals: Tek's Medical Validation Solution allows clients to select third-party reviews using one of the following processing options:
- Specialist In-Country Translators: professional medical translators who focus on translation quality and grammatical accuracy.
- Subject Matter Experts (SMEs): native speakers with the medical training and specialized skills required to ensure technical accuracy, audience relevance and up-to-date terminology. SMEs include highly credentialed and experienced MDs,nurses, anesthesiologists, chemists, biologists and other medical professionals.
The Benefits
In outsourcing the validation to Tek, this client reduced validation time by as much as two months for some languages.
- In addition:
- Validation was undertaken by qualified SMEs, using approved glossaries and providing a Certificate of Accuracy. This enabled the client to meet the standards required by in-country medical regulatory bodies.
- In establishing one uniform process for the insertion of changes to the text, the entire validation cycle was not only faster by up to two months, but also more accurate and less costly.
- In delegating the search for SMEs and the management of the validation process, the client reduced workloads for its own team members.
"The validation services offered by Tek Translation International have allowed us to reduce our time-tomarket in new regions by up to two months. Until now, we had been utilizing our international distributors to validate the translated materials. Priorities, dialect issues and the mitigation of differences would always add a few weeks to the process."
"Furthermore, the validation certificate supplied by Tek Translation International is just what our regulatory authorities require. This further simplifies the engineering release process." Client's Technical Support and Service Manager.
