Translation is a must when bringing a medical product to a foreign market. Traceable Standard Operating Procedures are necessary to comply with the FDA, EU Medical Device Directives (MDD, AIMDD, and IVDD) and other national and regional directives. Argo’s ISO 9001:2015, 17100:2015 and 13485:2016 compliance ensures that your documents are handled safely and securely with every project.
Reduce costly reviews and the risk of recall, and stay competitive all while complying with international and regional directives. Argo’s Regulatory Compliance Platform supports the full translation and localization life cycle, and it provides secure online access and reporting for each completed project detailing all contributors. The system also offers easy auditing with scanned and stored credentials for each linguist involved. These procedures are essential for any medical device or pharmaceutical company’s translation needs.
These are the most popular services we handle for the life sciences industry:
- ICFs (informed consent forms)
- IFU’s (instructions for use)
- Package inserts
- App localization
- Instruction manuals
Interested in launching an RFP for translation?
Download a sample RFP template you can use to immediately qualify a prospective translation vendor.
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