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Visit Aligned at MedConf 2012 in Luzern
January 2011
Visit Aligned at the MedConf 2012 Conference on Software- and System Design for Medical Devices, March 26-28, 2012 in Luzern, Switzerland.
Aligned participates as exhibiter during the conference and also features the talk "Design History File Management - Best Practices", conducted by Aligned CEO Anders Emmerich on March 26 at 10:10am
To make an appointment With Aligned, let us know your preferred time along with your contact details.
We look forward to see you there.
Date: March 26-28, 09:30 - 18:00
Location: Radisson Blu Hotel, Lakefront Center, Inseliquai 12, Luzern
How to get there
Read more about MedConf 2012 here.
Aligned Elements Importer for importing data from Word and csv files
December 2011
Aligned release the Aligned Elements Importer for data extraction from Word documents and csv files to Aligned Elements xml files.
The Aligned Elements Standalone Importer extracts and converts data from existing MS Word documents or csv files (such as excel files) into xml files that later can be imported into Aligned Elements projects.
The application applies the following procedure:
1) Load the source document
2) Designate the Aligned Element templates used for the target project
3) Map the data in the source documents to the attributes in the Aligned Elements templates
4) Extract the data and create an importable xml file
The Aligned Elements Importer also includes on-the-fly editing possibilities of the source information as well as testing the selected extraction and conversion settings before creating the resulting xml file.
The Aligned Elements Importer can be downloaded here.
Leading Brachytherapy company chooses Aligned Elements
November 2011
Varian Medical Systems Haan GmbH is a leading developer and producer of Brachytherapy solutions for the oncology market. For the company's Afterloader engineering, Varian Medical Systems Haan GmbH uses Aligned Elements to cope with their Design History File management.
"We develop devices, which use high activity radioactive sources to treat cancer, where risk management is one of the main drivers of our development process" claims Dr Günther Mondry, Afterloader Engineering Manager at Varian Medical Systems Haan GmbH.
"Integrating the risk management in our requirement, specification, and test management is essential in order to obtain the necessary regulatory clearance within our planned timelines.", Dr Mondry continues. "We have found no other system that rivals Aligned Elements’ ability in combining all of these parts of the Design History File compilation in a comprehensive manner."
Aligned Elements V1.7 SP 4 available
October 2011
Aligned Elements V1.7 Service Pack 4 (V1.7.0.42) is released, including:
1) Improved memory management of Trace Explorer for large projects
2) Improved project load performance for large projects
3) Optional display of gap information in gap form
4) Free text search including or excluding disabled objects
5) Risk summary based on queries
6) Saving last used Import settings
7) On-demand load of Project History View
8) Folder icon in Project and Trace Explorer
We have also added a number of fixes for over 40 reported issues.
Thoratec acquires Levitronix medical division
August 2011
The acquisition of Levitronix Medical follows a successful strategic partnership between the two companies. Thoratec, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts acquired the medical business of Levitronix.
Levitronix Medical has built a leadership position in magnetically levitated, bearingless mechanical circulatory support, with current and pipeline programs in cardiac and respiratory assist. CentriMag, Levitronix Medical's lead commercial product, is an extracorporeal, centrifugal flow blood pump used for short-term surgical support.
Thoratec is now integrating the Levitronix CentriMag acute circulatory support system into their product portfolio.
The CentriMag Design History File is documented using Aligned Elements.
Xeronics launches beta version of SiLA compatible LabwareMatch application
July 2011
Xeronics launches beta version of LabwareMatch, the first multi-vendor e-Catalog for labware product specification and implementation data for laboratory automation equipment.
LabwareMatch allows users to search for labware products by combinations of labware properties and lists compatible device models supporting the specific labware product. LabwareMatch provides labware specification parameter sets in SiLA standard format which can be downloaded for direct processing by the device software.
Xeronics and the SiLA consortium use Aligned Elements for managing their development documentation.
AMD SA, Belgium chooses Aligned Elements for DHF Management
June 2011
Advanced Medical Diagnostics SA (AMD) with headquartered in Waterloo, Belgium, is a company engaged in the development and commercialization of the HistoScanning™ technology. Prostate HistoScanning™ is a proprietary tissue characterisation technology developed to differentiate, characterise and visualize prostate tissue, based on the analysis of backscattered ultrasound.
AMD uses Aligned Elements to compile and manage the Design History File for HistoScanning portfolio.
Aligned participates as technology partner at Altran/ADL INSIGHT event
May 2011
In April, Altran and Arthur D Little shared their visions on how future challenges in the Life Science Industry can be mastered at a Medical Cluster INSIGHT event, taking place on the Altran premisses in Zurich.
The gathered audience, consisting of a large number of medical cluster members, were demonstrated how the experiences made by Altran and ADL have been used to solve number of life science and medical technology development cases.
Altran, one of the largest engineering and innovation consultant bureaus in Switzerland, has increasingly expanded its position as a significant player in the Swiss life science industry.
Since 2011, Aligned AG is one of Altran's technology partners and Aligned Elements is part of Altran engineering services. Aligned Elements is also used in the documentation management of the Altran FP7 projects, aimed to create a new innovation management platform for aeronautics, partly funded by the European Commission (see link).
Aligned Elements V1.7 SP 3 available
April 2011
Aligned Elements V1.7 Service Pack 3 (V1.7.0.38) is released, containing a number of corrections and a few new features such as inserting query results including chapter structure in word, display of multiple incoming traces in word, Search Result Report and partial Word 2010 compatibility.
Aligned Elements V1.7 SP 2 available
February 2011
Aligned Elements V1.7 Service Pack 2 (V1.7.0.33) presents a number of improvements. Automatic Risk summary, autorecovery of uncommited documents, three new validation rules and a number of performance improvements have been added to this release. Corrections have been made in the query, online-offline and word integration areas.
Aligned participates in Roche-initiated IEC 62304 knowledge-exchange group
January 2011
Aligned cooperates with a number of other swiss-based medical device manufacturers in experience sharing regarding the IEC 62304. In this joint effort, approaches, successes and mistakes are shared and evaluated. Themes discussed include software risk analysis, segregation, traceability, testing and much more.
Aligned Elements featured on www.anforderungen.ch
December 2010
www.anforderungen.ch is a swiss-based online community for Requirement Engineering, initiated by Dr. Samuel Fricker, senior research associate at the University of Zürich.
Aligned Elements is featured in a series of articles debating the requirement engineering particularities in the Medical Device Industry.
Levitronix awarded 510(k) clearance for the next generation of its CentriMag® Console and Monitor
November 2010
Levitronix GmbH (www.levitronix.com) has been awarded with a 510(k) clearance for the next generation of its CentriMag® System. The CentriMag® System controls and monitors the operation of a magnetically levitated medical blood pump.
A considerable part of the 510(k) application consists of documents generated and managed with Aligned Elements. "We are very happy to have been awarded with this 510(k). The smoothness of the application process exceeded our expectations." claims Viktor Steinacher, Project Manager at Levitronix, "In fact, FDA had virtually no comments on our 510(k) application and we are now able to release the next generation of CentriMag® System on the US market."
Aligned in cooperation with inmedis
October 2010
inmedis and Aligned expands cooperation to provide a broader spectrum of regulatory related products and services in the MedTech Arena. inmedis, located in Zug, Switzerland, has a long and proven trackrecord in the MedTech industry, providing efficient and pragmatic processes in areas such as risk management, process- and software validation, quality management and business software.
"The cooperation with inmedis has been a welcome complement for us.", claims Karl Larsson, Marketing Manager at Aligned, "The positive outcome of previous joint engagements has convinced us that a deeper cooperation will be highly beneficial for both parties. We are very pleased to count on inmedis as a business partner."
Aligned Elements V1.7 SP 1 available
September 2010
With the release of Aligned Elements V1.7 Service Pack 1 (V1.7.0.28), a number of performance improvements have been made available. Full-text search and attribute query performance has improved drastically, cutting the search time to a fraction of previous durations. The Export functionality has a received a brush up, with reduced memory allocation, improved performance and a new function to merge synchronization map files.
Aligned Elements V1.7 Service Pack 1 also includes three risk levels (acceptable, ALARP and inacceptable) instead of the previous two (acceptable/inacceptable) which also incorporate an expanded risk validation rule.
Aligned publishes free Regulatory Wizard and downloadable requirements for European Standard DIN EN980-2008 for graphical symbols.
Aug 2010
Aligned Elements presents a regulatory wizard for generating requirements derived from the European Standard DIN EN980-2008. The Wizard poses questions about the applicability of certain sections in EN980-2008 to the medical device in question and after completion automatically generates the corresponding requirements. The Wizard also generates a report documenting the users answer to each question which serves as a documented proof of the complete evaluation of the norm.
By downloading and applying the EN980 Wizard, all Aligned Elements users now have access to automatically generation of applicable requirements based on answers given during the Wizard run. The Wizard can be downloaded, free of charge, from [here].
Furthermore, for the Aligned Elements who what to make their own picking among the reconfigured requirements, all EN980 requirements are also downloadable from [here].
Aligned Elements V1.7 released
June 2010
Aligned AG releases Aligned Elements V1.7, a version where we have made an extra effort to expand the compatibility scope, improve reliability and performance. Aligned Elements is
a dedicated system for managing Design History Files to ensure exceptional transparency, consistency and control using a minimal effort.
Aligned Elements integrates the processing of Requirements, Specifications, Risks, Tests, Design Reviews and Defect Tracking with Traceability Management, automated Consistency Checks, bi-directional integration with Microsoft Word, Digital Signatures and much more.
“Aligned Elements V1.7 incorporates a large number of new features suggested by our existing customers, including improved Word synchronization, faster full text search, expanded query options etc. We have also made Aligned Elements x64 compatible and it now operates on Windows 7 as well as with SQL Server 2008." - claims Karl Larsson, Marketing Manager at Aligned
Levitronix releases next generation of CentriMag
June 2010
Levitronix GmbH (www.levitronix.com) launched the next generation of its CentriMag® Console and Monitor. The CentriMag® System controls and monitors the operation of the magnetically levitated medical blood pump. The system is CE approved and available for European market.
Levitronix uses Aligned Elements for its DHF documentation.
Business Case Study - Tecan saves time and money with modular DHFs
May 2010
Tecan - a leading player in the pipetting robot indcustry - manages to reduce their Design History File set-up time with up to 80%. By applying a modular DHF structure Tecan obtains an exceptional degree of DHF reuse, saving both time and money.
Download the full article here: [here]
IFTEST AG choses Aligned Elements
April 2010
IFTEST - Systems partner for industrial and medical electronics - EMS provider with a comprehensive service portfolio
Iftest AG is a systems partner for innovative industrial and medical electronics with a comprehensive range of services. As a reliable and skilled partner, Iftest AG has already had 25 years of success in the development and production of electronic devices.
IFTEST uses Aligned Elements to compile their product development documentation.
Turn the regulatory challenge into a competitive advantage
March 2010
"...By adopting a traceability tool, manufacturers can considerably reduce the time spent on compuiling regulatory documentation for market submissions. Aligned's Karl Larsson explains how...", in the April edition of Medical Device Developments.
Download the full article here: [here].
Aligned Elements supports Nunit integration
February 2010
Aligned Elements allows import of Nunit test results and the possibility to perform a large number of regular Aligned Elements-actions on these results. By combining the benefits of automated unit tests with the powerful analysis features of Aligned Elements, time is saved, quality is increased and trace coverage is expanded.
Read more: [here].
Download the integration package: [here].
Aligned releases Aligned Elements V1.6 Service Pack 5
January 2010
Aligned released Service Pack 5 for V1.6 on January 12th. This service pack includes full test search for linked projects, on-the-fly load of linked projects and visualization incoming traces from other projects along with a number of bug fixes.
Demonstration of Aligned Elements at Altran Event
January 2010
Altran – global partner for innovation – offers a platform for firms to get acquainted with the wide-ranging capabilities of Aligned Elements. The demo of this Design History File Management software will be held at Altrans Zurich Office in the end of January 2010 and in early March 2010.
Aligned participates at the Medical Cluster symposium "Fullfilling regulatory requirements using modern tools - Compliance made easy"
December 2009
Medical Cluster hosts the [INSIGHT] event "Fullfilling regulatory requirements using modern tools - Compliance made easy" where Aligned presents Aligned Elements for Design History File Management.
Aligned is invited together with inMedis, MAJESTY, bayoonet and Babtec to demonstrate how their products can make the regulatory challenges easier to deal with.
The event takes place on January 26th in Museum Franz Gertsch in Burgdorf. To attend this event please use this link |Apply| and send in your application.
Aligned releases Aligned Elements V1.6 Service Pack 4
November 2009
Aligned released Service Pack 4 for V1.6 on November 17th. This service pack closes a limited number of open issues regarding handling of MS Word instances, error reporting and linked projects.
Aligned exhibits at Swiss Innovation Forum, Basel on Nov. 5th
October 2009
On November 5th 2009, Aligned exhibits at the Swiss Innovation Forum in Basel. We have been invited to participate as a partner of Altran (Stand 24). The 4th Swiss Innovation Forum will take place at the Congress Center in Basel. Your registration will be accepted under following link: registration
We look forward to see you there.
Aligned releases Aligned Elements V1.6 Service Pack 3
October 2009
Aligned released Service Pack 3 for V1.6 on October 18th. This Service pack focus on reliability with more than 90 open issues closed.
Enigma Diagnostics selects Aligned Elements
September 2009
Enigma Diagnostics Limited is a recognised leader in developing rapid diagnostics for the detection and identification of infectious organisms, such as bacteria and viruses, in environmental, clinical and biological samples.
Enigma develops portable and totally automated PCR (polymerase chain reaction) based diagnostic instruments that provide rapid and decisive results in real time allowing the user to take immediate action at the point of care.
Enigma has chosen Aligned Elements for its Design History File Management.
Aligned is now member of Medical Cluster
September 2009
As of September 2009 Aligned is official member of the Swiss Medical Cluster. The Medical Cluster brings together manufacturers, suppliers, service providers and research and development firms along the medtech value-added chain from throughout Switzerland. The association has more than 100 members.
More information about the Medical Cluster can be found at www.medical-cluster.ch.
Endosense receives CE mark for Tacticath® force-sensing ablation catheter
August 2009
We are happy to announce that one of our customers, Endosense, a medical technology company focused on improving efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has received the CE mark for its TactiCath system. The first and only force-sensing ablation catheter developed worldwide, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure.
The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium.
“The CE mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrythmias,” said Eric Le Royer, president and chief executive officer of Endosense.
Endosense uses Aligned Elements for managing the Design History Files of their products.
Aligned releases Aligned Elements V1.6 Service Pack 2
June 2009
Aligned released Service Pack 2 for V1.6 on June 14th. This Service pack focus on security issues and closes a number of open defects reported for V1.6 SP 1.
Tecan uses Aligned Elements E-Signatures in their Design History File Management
June 2009
Tecan AG is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics, and clinical diagnostics. Tecan specializes in automation solutions for laboratories in the life sciences sector. Since 2007, Tecan is using Aligned Elements to manage its Design History Files and have made extensive use of the capabilities offered by the product. In an effort to increase productivity, Tecan has decided to use Aligned Elements' Electronic Signatures to speed up the sign-offs of a number of DHF relevant documents.
Jan Cart, System Engineer, "We have targeted a set of deliverables where we think electronic signing will increase our productivity substantially vis a vis relying on hand-written signatures. Since Aligned Elements offers this possibility, we are eager to see what it can do for us. We will soon have 16 R&D team members equipped with electronic certificates for a pilot project. Hopefully we will see the results pretty soon."
Mario Billia, Risk Manager R&D, claims: "FDA has clearly pointed out that it endorses DHF's being submitted in electronic format and it further supports this path by explicitly accepting electronic signature based on the X509 V3 standard. I am of the opinion that the acceptance by FDA allows us to further explore these opportunities and find out how they can increase our own productivity."
The SiLA consortium for Standardization in Lab Automation chooses Aligned Elements
May 2009
The SiLA consortium, consisting of leading manufacturers, software suppliers, system integrators and pharma/biotech corporations, develops a new interface standard for rapid integration of lab automation systems. System procurers of lab automation systems, integrators and device suppliers shall all benefit alike from a common standard for device control and data interchange. Members of the consortium include Novartis Pharma, Roche, Actelion, Tecan, Hamilton, Perkin Elmer, Agilent Technologies and Thermo Fisher.
SiLA has chosen Aligned Elements for documenting, managing and monitoring the SiLA Interface Standard Requirements and Specifications.
More information about SiLA can be found at www.sila.coop.
Qiagen Instruments uses Aligned Elements with Citrix for flexible multi-site access
May 2009
Qiagen Instruments is a multinational actor in the sample and assay technology industry with a large multi-site R&D organization. Qiagen applies Aligned Elements for DHF Management and a significant part of the Project R&D team is constantly involved in the ongoing DHF activities.
"With our Team residing on two different physical sites (one in Germany and one in Switzerland), we had a situation where the performance of Aligned Elements was impaired from our current IT infrastructure. The data transfer capacity between the two sites did not correspond to our new needs and we had to do something to improve the performance." says Mr Roger Hueppi, Project Manager.
"We decided to place Aligned Elements in our existing Citrix environment and see what happened. The performance improvemed strongly. Operations that previously took minutes now occur within seconds.Our productivity has improved accordingly.", continues Mr Hueppi.
"As a further benefit, the Aligned Elements client is also available over our Citrix Web Interface which makes it possible for external team members to access our DHFs."
"Since we have trained over 50 users on Aligned Elements there were a considerable number of Aligned Elements client installations to maintain. With our migration to Citrix, a significant maintenance reduction could be achieved for the two local IT teams.", Mr. Hueppi claims. "Right now, we see only advantages with this approach."
Aligned releases Aligned Elements V1.6 Service Pack 1
Apr 2009
Aligned released Service Pack 1 for V1.6 on April 6th. This Service pack focus on performance improvements and closes a number of open defects reported for V1.6.
Aligned publishes preconfigured DHF content for Aligned Elements
Mar 2009
Aligned Elements presents an array of free downloadable content for Aligned Elements V1.6.
The preconfigured content which includes UserGroups, Queries and Export Transformations, can be imported in any Aligned Elements V1.6 client. See more information [here].
"We hope that this content will give our users and customers a valuable head-start when it comes to using Aligned Eements for documenting their Medical Devices." - states Karl Larsson, Director of Marketing. "This content which can be donwloaded from our website, can be used instantly. No installation is needed."
Aligned Elements V1.6 released
Feb 2009
Aligned AG makes their DHF Management system “Aligned Elements” even more attractive for the Medical Device Industry. Aligned Elements is
a dedicated system for managing Design History Files to ensure exceptional transparency, consistency and control using a minimal effort.
Aligned Elements integrates the processing of Requirements, Specifications, Risks, Tests, Design Reviews and Defect Tracking with Traceability Management, automated Consistency Checks, bi-directional integration with Microsoft Word, Digital Signatures and much more.
“We have made Aligned Elements V1.6 even more attractive for the Medical Device industry by making Industry Regulations an integral part of the system. You can now check how well your DHF content matches the rules of given norms and regulations. Furthermore, we have managed to seamlessly integrate Defect Tracking Items from external systems such as Altassian’s “Jira” and the Open Source System “Trac”. These Items can now be managed and traced from within the Aligned Elements Client.
REMP has chosen Aligned Element
Jan 2009
REMP develops and produces devices, consumables, software and fully automated sample processing and storage systems mainly used in
Research and Development by the world's leading pharmaceutical and agrochemical companies.
REMP products include systems and services, workstations, consumables and software applications for sample storage and retrieval, cherry-picking, climate control down to −80° C, plate replication and reformatting, powder dosing, vial weighing, tube capping and uncapping, thermal sealing, and piercing.
Since the beginning of 2009, REMP has decided to use Aligned Elements for their Design History File Management.
Qiagen Instruments goes with Aligned Elements for DHF Management
Dec 2008
Qiagen (NASDAQ: QGEN), a global leader in sample and assay technologies, has chosen Aligned Element to assist their Design History File Management process.
Qiagen provides hundreds of high quality products accorss a range of markets including Life Science, Pharma, Applied Testing and Diagnostics.
This multi-million dollar corporation develops highly complex products, bringing together expert competencies in chemical assays, modulare hardware, software, consumables and process integration. With over 34 multinational sites, the coordination effort of DHF's is going to be supported by Aligned Elements keeping several thousands of items under design control.