FDA Compliance - Techlink

The Only Provider Certified in Both: Translation and Compliance

TechLink International is a leading provider of certified translations to the medical device, biomedical, and pharmaceutical companies. TechLink International has been delivering multilingual compliance solutions in more than 20 languages to the Medical and Surgical Device Manufacturing, Biotechnology, IVD, Healthcare and Pharmaceutical industries as well as to Clinical Research Organizations (CROs) healthcare research centers. We only work with certified medical translators who possess significant experience in their field of specialization and are subject-matter experts. Many of our translators and editors hold MDs and PhDs in all major areas of life sciences and medicine.

Our Services:

Translation, Editing, Proofreading

We provide excellent quality technical translations in any language combination. Our translators work hand to hand with our compliance engineers adapting the text into FDA compliance. We combine linguistic professionals with technical expertise and work on all stages of and aspects finalizing your project with accuracy, clarity, technicality and readability by the target audience.

Layout & Graphics

We will deliver a ready to translated and compliant ready to print documents in the application specified: PC and Mac platforms, MS Office (Word, Excel, PowerPoint), Adobe CS4 (InDesign, Illustrator, Photoshop, FrameMaker), Quark Xpress.

Translation of Website Content

Ensures the website is translated in a linguistically and technically appropriate way. Vocabulary, grammar, punctuation, style, technicality and compliance are considered to make sure the language used reflects the not only target audience but also the local legal requirements.


  • Case Report Forms
  • Clinical Trials
  • Drug Registration Documentation
  • IFUs and inserts
  • Informed Consent Forms
  • Installation Manuals
  • Labeling
  • Marketing Collaterals
  • Operating Manuals
  • Packaging and Labeling
  • Patents
  • Patient Information
  • Patient Questionnaires
  • PowerPoint Presentations
  • Protocols
  • Software Application Interface
  • Toxicology Reports
  • User Manuals
  • Web-based Content (xml, html, sgml)
  • Complete graphic design service
  • Ready to pre-press files

Quality Assurance

TechLink International combines the language knowledge with the regulatory compliance. We are experts in linguistics and in the industry. We are a ISO 9001 (International Organization for Standardization) certified and FDA consultants for manufactures of the Medical Devices and Pharmaceutical industries. We employ only professionally accredited/member translators of the American Translators Association (ATA) or other governing body.

Software Validation

Techlink International provides software validation for minor, moderate and major device classifications for the FDA. Techlink International can create a whole new software document dossier or amend the current dossier per the FDA regulations and requests.

Your Trusted Source For Compliance.