Getting much-needed medical devices to international markets can be a long and tedious process. At CQ fluency, we specialize in precision navigation of the highly complex. We identify and successfully address all the hurdles especially those that deal with submissions and labeling of devices and cultural competence.
medically and technically accurate translations
Your language compliance partner with an accredited team of medical translators experienced with regulations, such as EU MDR and IVDR. We manage the full scope of medical device translations, including but not limited to:
instructions for use
Protect patient safety through proper medical device with accurate translations of device instructions.
medical device operation manuals
Ensure identical end-user experience of your medical device with accurate operation manual translations.
Fully translated and localized medical device product details and ordering information.
medical device software localization
Robust automated workflows to detect and implement localization changes to your medical device software.
package inserts and labelling
Regulatory assessments of local label and packaging laws required for multinational clinical studies.
Global regulatory reviews to ensure your documents are in full compliance with requirements, such as US FDA and EU MDR/IVDR.
Our team includes 1,500+ certified medical translators and editors
Our medical and biotechnical communications are:
- Consistent with the needs of health care providers
- Understandable to patients wherever the devices are used
- Properly labeled
- Conformed to global and local government regulations
Our ISO 9001 and 17100 certified quality control systems were designed to fulfill the exact standards of the healthcare, pharmaceutical, and biotechnology industries. Finally, our CQ Quality Care customer service ensures that getting a medical device to any market is a smooth and streamlined process.