Polarion Software´s Powerful Solution Enables IEC 62304 and FDA 21 CFR Part 11 Regulatory Compliance for Medical Device Companies
Now there´s a turn-key lifecycle management solution for compliance with critical regulations governing the medical device industry, including FDA 21 CFR Part 11 and IEC 62304: introducing MedPack from Polarion Software.
Software reliability within computer controlled medical devices, such as pacemakers, presents a significant risk for medical device manufacturers, who must prove compliance to regulations established to protect against personal injury, and most critically -- loss of human life. FDA and IEC regulations demand that companies put in place, and prove through an auditing process, a rigorous lifecycle and requirements management process that ensures device quality and mitigates risk. Failure of an internal audit can result in steep financial penalties for a manufacturer, and potentially, a shut-down of manufacturing operations.
Today, it is virtually impossible for medical device manufacturers to verify software quality and process integrity post-development without a comprehensive application lifecycle management (ALM) solution. Polarion´s MedPack plug-in leverages our already proven-in-production turn-key ALM and RM solution to provide medical device manufacturers with an automated and cost-effective pathway to regulatory compliance.
Further information on Polarion's Medical Solution is available from Polarion Software´s web site.
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News
New Customers:
Polarion is happy to welcome numerous new customers for the Polarion Requirement and Application Lifecycle Management Product such as: Robert Bosch GmbH, Phoenix Contact, Küster ADS, Diers International, Daimler AG, Siemens IT Solutions, Sony DADC, Decision Lens, General Electric, Stanley Associates.
CSC Selects Polarion ALM for Global Partnership:
Computer Science Corporation (CSC) and Polarion have signed a global partnership agreement that allows CSC to integrate Polarion ALM software into the CSC Product Suite for insurance companies. For more information please contact
GSA Contract:
Polarion Software is now listed on the GSA Schedule to provide easy access and better service for our growing number of US Government customers. For more information please contact:
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How to import Requirements from MS Word into Polarion
The MS Office Word Importer for Polarion (“Importer”) allows requirements and other data currently in MS Office Word format to be imported as work items into Polarion for reuse without needing to recreate them in the Polarion portal. Nick Entin, VP Research & Development of Polarion Software, wrote a great step-by-step instruction, describing how to set up, prepare and use the Importer. Of course, he is also sharing some great tips and best practices.
Read the whole how-to in our Polarion Weblog
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Polarion Pop Challenge 2010
What would your boss say if you handed over $10,000 worth of Polarion licenses? Would you get to keep the spiffy new Apple iPad that goes with it? You'll never know unless you enter the Polarion POP Challenge 2010! Got an idea for an extension? Got one already developed or in the works? This is your chance to show off your ideas and skills and gain recognition from the entire Polarion community The clock is ticking down to the April 30, 2010 submission deadline so don't delay – get your Polarion extension in the running as soon as you can.
The Polarion POP Challenge is one contest where everybody wins. Every extension submitted will be published on the Polarion POP extensions portal, gaining you recognition in the fast-growing Polarion Community. Even if you never create an extension, you may still come out a winner when some of the new extensions that come out of this contest help you do things better and faster than ever.
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Free Subversion Training Curriculum: SubTrain
The new version of the free Subversion Curriculum SubTrain 1.65 is really more than just a service release: we have added a whole new course for
"advanced merging and branching". Packed with best practices but also with
dangerous practices this course is ideal to leverage your Subversion skills
to a professional level.
- Branching Strategies (feature branches, developer branches, bug fix branches,
release branches, platform branches, experimental branches, vendor branches)
- Merging with Subversion (reintegrate branches, cherry picking, ancestry)
- Dangerous merging
- Best practices – dos and don’ts
For Release Notes, Fixed issues and to download SubTrain, go to our SubTrain page.
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