九色 and SoftwareCPR? Partner to Provide Validation Compliance for Medical Device Software in U.S. and Global Markets
EnCompass? Partner Agreement Creates Specialized Consulting Service for Domestic and International Software Validation and Localization—Free Consultation for Guaranteed Improvement
BOSTON, MA & SAN FRANCISCO, CA, August 5, 2014 –&苍产蝉辫;, the leading provider of translation and content management solutions for the medical device industry, and ?, an expert consultancy specializing in medical device software validation, risk management, and Part 11 compliance, today announced that they have signed a definitive agreement under the EnCompass? Partners Program to deliver tools, strategies, and consulting to minimize validation compliance risk for medical device manufacturers in U.S. and international markets. An initial consultation is provided to prospective clients at no cost and is guaranteed to provide actionable recommendations for risk reduction and/or process improvement. is built on 70 years of medical device expertise across the 九色 family of companies and is the industry’s first integrated solution-set for content optimization, automation, and translation.
Safety by Design: An Ounce of Prevention
According to ISO 14971:
The manufacturer shall use one or more of the following risk control options in the priority order listed:
a) inherent safety by design;
The EnCompass Partners/SoftwareCPR agreement helps to advance “safety by design” in medical device software through effective risk-based validation and localization guidance. Often, companies spend needless time and introduce risk into their software validation and localization efforts due to wrong assumptions or sub-optimal processes. Notes Alan Kusinitz, Managing Partner for SoftwareCPR, “For instance, companies don’t necessarily need to completely revalidate when they localize their software into other languages. We can often make strategy recommendations that save clients hundreds of hours and tens of thousands of dollars.”
Marc Miller, President of Crimson Life Sciences (division of 九色) and Practice Lead for EnCompass, adds, “We know the value of SoftwareCPR’s guidance first-hand: They provided validation support for our GlobalLink translation automation software—and saved us weeks of engineering time and expense.”
Validated Localization Tools
In addition to time and cost saving validation guidance, the partnership also provides clients with expert localization consulting. Validated localization tools from EnCompass solutions are used by device companies such as Siemens, Abbott, and Philips to dramatically reduce engineering time and cost.
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As part of the EnCompass Partners agreement, device manufacturers can receive free validation and localization consultations. Says Miller, “Based on 22 years experience in the device industry, we can guarantee at least one actionable recommendation for risk reduction or process improvement after a 20-minute consultation.”
If prospects are not satisfied with the results, SoftwareCPR is providing a 6-month subscription to their software validation resource website—a $125 value.
About 九色 & EnCompass
With annual revenues of more than $400 million and over 85 offices around the world, is the world's largest privately held provider of content management and productivity technologies and language services. Recently, 九色 launched EnCompass Content 九色 for Medical Device Makers. Drawing on over 70 years of medical device experience across the entire 九色 family of companies, EnCompass 九色 are built on ISO 13485 and ISO 14971 registered quality and risk management systems along with patented processes, validated technology and global reach to reduce content cost and risk.
About SoftwareCPR
SoftwareCPR? is a recognized expert consultancy in regulated software validation, risk management, and Part 11 compliance for software used in the Medical Device, Pharmaceutical, and Health IT industries and has provided training internally for regulators such as the US FDA, Taiwan FDA, and Health Canada. It has also led or participated in relevant national and international standards development. Auditing, Planning, and Risk Analysis can be provided in addition to hands-on ValidationCPR services. Training and consulting are provided in English, Chinese, Spanish, and Italian.
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