Moravia helps producers reach international markets with the following portfolio of key services that are customized for the life sciences industries:
Translating materials such as Instructions for Use (IFU) documents, printed documentation, manuals for patients or physicians, packaging, labeling and marketing communication materials. Thanks to our established processes, managed review cycles, as well as qualified linguistic and professional medical resources located in-country, we ensure consistent translations that meet local regulations.
Delivering desktop publishing services that ensure translated documents such as packaging, labeling or IFUs are delivered - print or online-ready - in any language, in any format, and with the same quality as the original version.
Providing - or managing on behalf of clients - review cycles designed to guarantee the quality and local compliance of translated content. This includes verifying technical accuracy and factual correctness by medical professionals and practitioners located in-country, as well as standard linguistic quality checks carried out primarily by linguistic resources. A well set up and managed review process can help significantly reduce the lengthy turnaround times often associated with review cycles.
Managing the complete terminology process, including creation of new or evaluation of existing glossaries and their ongoing maintenance; creation and maintenance of linguistic style guides; online query management; and Translation Memory maintenance. Efficient management of terminology in life sciences is a key contributor to quality and consistency, and frequently also an area where major efficiencies can be obtained.
Managing the overall medical device translation process and the many varied resources involved. Moravia has developed a robust process specific to Life Sciences, and runs this with experienced Project Managers who are trained in structured project management techniques. Sound project management will ensure meeting the ubiquitous - but frequently seemingly contradictory - goals of quality, time and cost control.
Localizing the software component of medical devices. This includes software applications, such as software for programming a medical device, or embedded medical device systems, such as remote patient information access systems. Whether the software component runs on a standard or a proprietary platform, Moravia will ensure its appropriate country and language-specific localization, as well as localization of associated help or documentation.
Performing functional, localization or globalization testing of a device software application or a medical device system, and fixing any defects identified. Among other testing and engineering services, Moravia performs linguistic testing by qualified resources to ensure the localized product contains no factual or linguistic errors and fully meets the local requirements.
Producing localized versions of the many and varied types of multimedia that exist related to medical devices, be it materials for end-user consumers or reference and training materials for product or medical specialists.
Helping clients to address language technology challenges and to design new - or optimize existing - translation and localization processes specific to life sciences. Our focus is on implementing best practices related to the complete multilingual process that a medical device product undergoes throughout its lifecycle.
In-country Review (ICR) Process
Managing in-country reviews (ICRs) has become one of the key elements of an efficient translation process. Over the years, Moravia has built and trained a unique network of in-country medical professionals, practitioners and reviewers, for a wide range of medical areas and languages. As part of our process, we provide two types of independent in-country reviews that complement the standard translation editing and proofreading steps.
One is for technical accuracy and factual correctness, carried out by medical professionals and practitioners, who have the practical experience in the subject area in the given country. This means they can assess with authority the accuracy and usability of the text in the local context, for the specified use, and how it complies with the local practices and context.
For the second type, linguistic quality verification, we work with our qualified linguists who specialize in life sciences, and who ensure the translation, stylistic and terminological correctness and consistency of the translated material.
Managing the implementation of changes from reviews is an equally important part of the process, given the regulated nature of the industry. Moravia's language leads assess the proposed changes in terms of how they comply with the client's general and project-specific guidelines and they work with the client to resolve any discrepancies and record and document their resolution.
We normally manage in-country reviews using our network, however, we have also won the trust of our clients to communicate with and manage their own medical reviewers. In this model, we ensure a smooth inclusion of the review process in the overall translation workflow, which helps to increase its efficiency, and typically reduces the time and costs required for managing the process and the clients' associated internal overhead.
Quality Approach & Process
Moravia's production team is experienced in handling the diversity and challenges of medical projects, integrating with the customer at different points in the product life cycle to handle all translation requirements. Our ISO 9001:2009-certified Life Sciences Practice team includes the following qualified professionals:
- Life Sciences Linguistic Specialists
- Subject Matter Experts in our in-country teams
- In-country Language Leads
- Qualified in-country translators and proofreaders
- Moravia Third Party Life Sciences reviewers - in-country review (ICR) resources with either linguistic or medical background
In the situation where even a small mistake can have dire consequences, Moravia has built a robust translation and QA process which is designed to eliminate any margin for error, and takes into account the often necessarily subjective assessment of linguistic quality. Access to in-country medical professionals practicing in the field of expertise is available for consultancy to translation teams during the translation phase.
The QA process includes full linguistic proofreading by a proofreader within the translation team and a third party QA by an independent Moravia reviewer with knowledge of both linguistic and medical aspects of the subject matter. An important part of the QA process is the inclusion of detailed QA instructions and comments for use by the reviewers and the translators.
Moravia's Life Science QA metrics are based on industry translation standards, but go further, and build on the strictest requirements life sciences companies have to meet regarding local regulatory approval from a quality and process viewpoint.
Life Sciences Partner Selection
To achieve high-quality medical translations, Moravia Worldwide uses a network of in-country language experts with teams qualified based on subject matter expertise. With the diversity of the medical device (and pharmaceutical) industries in the life sciences sector, it is essential to assign suitable language experts.
Moravia maintains a rigorous process for qualifying, training and developing our in-country life sciences partners and resources. Our demanding qualification process ensures that linguists:
- Pass a rigorous screening and testing process
- Have extensive experience translating life-science texts
- Receive continuous performance feedback
Some of the key steps in the process are:
- Initial qualification Including research for qualified resources; assessment of profiles available; tests and test assessment; completion of a pilot project and a subsequent post mortem evaluation of the pilot project.
- Performance monitoring at project level Carried out by production teams on an ongoing basis.
- Operational assessment (regular basis) Including formal partner evaluation and an internal assessment by Moravia Project Managers and our Linguistic Specialists Group.
- Business reviews (regular basis) Done via on-site visits, phone, or by invitation to our regular Moravia Partner Summits.
With this process, Moravia has the capacity to deliver consistent and quality translations to life sciences customers, and the scalability to meet their growing needs, whether for their traditional markets or the newly emerging markets they wish to enter.
The Role of Multilingual DTP
With much of the multilingual content needed in print form to complement increasingly frequent online delivery, DTP plays as important a role as translation does in ensuring patients and consumers receive accurate information about products. It is translated materials in the process stage immediately after the full DTP process that are often used to assess compliance, and even a minor formatting mistake can lead to catastrophic consequence.
This means truly zero tolerance for formatting errors is needed, and Moravia uses a specific DTP process with multiple DTP QA checks and special automated checking tools to ensure accurate materials are produced at every stage of the translation process, up to and including final delivery.