Crimson's efforts to improve and perfect the translation of labeling should be an integral part of any [manufacturer's] risk management system. – Dr. Harvey Rudolph, co-author of ISO 14971:2000, 25-year FDA veteran, co-chair of the US Technical Advisory Group for Risk Management
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.
Patent Pending Risk Management
Based on the world's first ISO 14971-registered risk management system, Crimson files the industry's first translation risk management patent.
ISO 14971:2009 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 first 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 9001:2008 Certification
Crimson's QS, certified to ISO 9001:2008 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. Crimson offers you the most specialized and mature translation quality system in the industry.
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.
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.
