When you choose Crimson, you get standards-based processes and regulatory peace of mind. Our professional credentials are unmatched in the translation industry – providing you with clear-cut evidence (for you, your Registrar, and your Notified Body) of compliance with important labeling risk management requirements.

ISO 14971:2000 Registration ISO 14971 has been recognized by FDA, Health Canada, the EU, Japan, and Australia as the risk management standard for medical devices. Crimson was the first company to successfully register to ISO 14971. The registration audit was conducted by Dr. Harvey Rudolph, a co-author of the standard, 25-year FDA veteran, and former Global Program Manager for UL’s medical device practice.

ISO 13485:2003 Certification Crimson is the only translation company in the world to hold a certification to ISO 13485:2003 – the QS standard designed for medical device companies and their critical suppliers.

ISO 9001:2000 Certification Crimson’s QS, certified to ISO 9001:2000 since 2002, is specially designed for medical translation (as defined in our QS Scope), was implemented by a medical QA consultant, and certified by a medical auditor. No other translation company can match our level of QS specialization.

ISO 14971:2000 Endorsement As early as 2002, Crimson had received official endorsement to ISO 14971. The company’s risk management system has since been developed, audited, and registered to ISO 14971 under a first-of-its-kind service from UL and Dr. Harvey Rudolph.

Notified Body Endorsement Crimson's use of the SAE J2450 translation quality standard has received official Notified Body approval for translation Resource and Process risk management. Crimson’s process has also received Notified Body support as an effective means for auditing existing (legacy) translated material.

Patent-Pending Risk Management Process Crimson’s process for managing translation risk at both the resource and process level is so effective, we have a patent pending.

Eliminate Distributor Review: Notified Body Approval Crimson’s risk management processes have received Notified Body approval as an effective substitute for full-document Distributor Review. With Crimson’s translation risk management measures in place, you can safely eliminate this onerous, costly, and time-consuming step.