Vendor Guidelines for Life Sciences Sector
What this page is for
This page is to share with vendors important information and considerations when working on translation work for medical customers.
Our translation workflows are structured around internationally recognized ISO standards, including ISO 13485 for medical devices. These standards define both system-level controls embedded in our Translation Management System (TMS) and operational responsibilities. Our ISO standards work together to create a controlled, compliant framework for medical translation projects. For that reason, it’s critical that this short guide is read and understood to ensure that ISO 13485 requirements for Life Sciences standards are consistently met in our translations.
Brief introduction to Life Sciences Sector
The life sciences sector encompasses several disciplines: pharmaceuticals, biotechnology, biomedical, medical equipment, medical consulting companies, etc.
The two main umbrellas are:
- Pharmaceuticals: Pharmaceuticals relate to the production of medicine. This encompasses research, development, clinical trials, patenting, production, marketing, etc. of pharmaceutical medicine.
- Medical devices, or medical equipment: any product, instrument, software, material, apparatus or other article that is intended for a medical purpose.
Translations in this sector are high risk because they can directly affect patient safety, regulatory compliance, and clinical outcomes.
Your key responsibilities when working on Life Sciences translations
- Prior to accepting a job invitation, check the source content and read all instructions and briefings carefully.
- Ensure that the content and project requirements align with your areas of expertise. If you have any doubts about your qualification and/or ability to meet specific requirements, do not accept the job and instead contact the project manager to clarify any doubts.
- Follow all customer instructions, which are usually provided in Message to experts, Job briefing, Company briefing, and Reference files.
Working with controlled documents and resources
- Any specific instructions in the briefings regarding TMs should be strictly followed.
- Always work only with source files and reference materials provided through our official channels (TMS, secure email).
- Glossaries and terminology should be strictly followed. Access to glossaries could be offline or online in our TMS, depending on the workflow.
- Proper utilization of any regulatory templates and dictionaries.
Translation process, tools, platforms and queries
- Follow the required workflow:
- Receive assignment and read all instructions
- Translate
- Perform a thorough self check
- Deliver final files as instructed
- Preserve all warnings, contraindications, and safety statements in the translation.
- Double check all numbers, units, and dosage information.
- Never use unauthorized tools or platforms.
- Raise a query whenever the source text is ambiguous or seems incorrect.
- Resolve any questions or doubts about instructions, terminology, source text, etc. prior to delivering the translation.
- For queries, you should reach out to the project manager via the messages in our TMS.
How we work together
- Any feedback or error reporting on the terminology, TM, source content, etc. should be shared during the translation prior to delivery.
- By accepting medical and pharmaceutical work, you acknowledge that it is very high-risk content and implies an understanding that stricter checks and reviews are needed.
Final check before delivery
Before delivering any medical or pharmaceutical job, confirm that:
- The approved terminology has been strictly followed throughout the translation.
- If regulatory templates or disclaimers are needed, they have been properly implemented and match the approved wording and format.
- All product and drug names exactly match the approved terminology.
- All numbers, units, and decimal separators are consistent and correct.
- Any reference files have been referenced during translation.
- All briefings and instructions have been followed.
- All queries are resolved or clearly documented.