Services: Medical Validation
Stringent healthcare regulations can slow time to market
The life sciences industries face substantial challenges in bringing new products into a highly competitive and strictly regulated global market.
In the pharmaceutical industry, you operate within a web of regulations governing every aspect of a product’s life cycle, from production processes to product labeling and instructions.
And these regulations are ever increasing, as agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan's Ministry of Health, Labor and Welfare (MHLW) act to protect public health.
Further in-country regulations only add to the challenge of getting healthcare products to the worldwide marketplace before the competition does. Medical device manufacturers, in particular, also typically comply with quality systems standards (ISO 13485) and the risk management standard (ISO 14971).
A key common requirement for all life science products is that they be provided to the user or patient with information that allows them to use the product safely. Incorrect labeling or information and inaccurate translations could cause adverse reactions or incidents and pose a threat to health and safety. In these cases absolute accuracy in translation is not a "nice to have," it’s a matter of vital importance.
Tek’s global experts validate and certify medical translations fast
Tek Medical Validation Service has the right people, processes and tools in place to help you reach the global marketplace with speed and confidence. No matter how complex the material or how strict the in-country regulations, partnering with us is simple.
You let us know which translated materials need validating and we:
- Compile an online glossary for terminology consistency
- Acquire the best in-country experts to validate and certify the translation
- Manage the entire process with specialized on-line efficiency tools
- Provide you with translation certification documentation to help you meet compliance with in-country regulations.
Four good reasons to choose Tek’s Medical Validation Service
1. Two types of third-party medical validation experts
- Specialist In-Country Translators
- Professional medical translators
- Ensure:
- Translation quality
- Grammatical accuracy.
- Subject Matter Experts
- Native speakers with medical/scientific expertise
- MDs, anesthesiologists
- RNs
- Chemists, biologists
- Ensure:
- Technical accuracy
- Audience relevance
- Current terminology.
- Native speakers with medical/scientific expertise
- Enterprise Terminology Management Solution – 3 step process
- Evaluation of customer’s language assets by linguistic experts
- Glossaries and style guides complied and approved at project outset
- Deployed and shared by all project linguists
- Language QA Solution
- Automates quality checks to identify pass or fail rate
- 2nd quality check by specialist LQAers, qualified nationals located in-country
- Tek’s Validation Management Module
- Works within the Tek OneWorld Platform
- On-demand project schedules, progress reports
- Facilitates linguistic and technical QA
- Ensures:
- Better communication
- Faster sign-offs
- Efficient project management.
Your professionally validated files are delivered with a Tek Certificate of Accuracy
- Ensures:
- Fulfillment of your compliance obligations
- Peace of mind.
Tek’s experience, efficiency and expertise works for you
With over 17 years providing globalization services to many of the top 10 life science companies, Tek has a deep knowledge base of the medical devices, medical diagnostics, pharmaceuticals, biotechnology, and consumer healthcare sectors.
- We have the experience to:
- Adhere to the stringent regulatory controls in the life science industries
- Deliver on time to meet ever-shortening software and product release cycles.
- We have on-line efficiency tools that:
- Manage project workflow and centralize communication
- Enforce terminology consistency and expedite QA.
- We have the in-country experts available that:
- Possess the appropriate credentials and skills
- Understand the nuances of the local environment
- Certify the medical validation services they provide.
