BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--TransPerfect, the leading provider of translation and content management solutions for the medical device industry, and SoftwareCPR®, 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. EnCompass Content Solutions for Device Makers is built on 70 years of medical device expertise across the TransPerfect 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 TransPerfect) 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.
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 TransPerfect & EnCompass
With annual revenues of more than $400 million and over 85 offices
around the world, TransPerfect
is the world's largest privately held provider of content management and
productivity technologies and language services. Recently, TransPerfect
launched EnCompass Content Solutions for Medical Device Makers. Drawing
on over 70 years of medical device experience across the entire
TransPerfect family of companies, EnCompass Solutions 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.
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.