Regulatory Credentials

Due to issues of patient safety and regulatory compliance, risk management is a critical consideration for every medical device manufacturer. Since its initial publication over 10 years ago, ISO 14971 has become the device industry’s standard for effective risk management.

Among the most important requirements described in ISO 14971 is management responsibility (section 3.2), including the requirement to reference “state of the art” when determining risk acceptance:

Top management shall provide evidence of its commitment to the risk management process by… determining criteria for risk acceptability; this policy shall…take into account available information such as the generally accepted state of the art…

The risk management significance of “state of the art” is specifically cited no fewer than 12 times by ISO 14971.

According to Steve McRoberts, Global Principal Engineer – Medical Regulatory Programs at Underwriters Laboratories (UL): “By seeking to reduce patient safety errors, the Crimson patent certainly advances ‘state of the art.’” In other words, Crimson's patented process helps you meet important risk management requirements for translated labeling. 

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

Patented Translation Risk Management
Based on the world’s first ISO 14971-registered risk management system, Crimson holds the world’s only patent for medical device labeling translation. Crimson’s patent advances “state of the art” for labeling risk management and helps device makers satisfy important ISO 14971 requirements.
ISO 14971 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 Certification
Crimson is the first translation company in the world to hold a certification to ISO 13485 — the QS standard designed for medical device companies and their critical suppliers.
ISO 9001 Certification
Crimson's QS, certified to ISO 9001 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.




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