Aligned Elements Product News

May 25 2020

Aligned Elements V2.5 Service Pack 3 (2.5.313/114.16963) is here with a great improvement and some important fixes.

What's New 

Collaborate using Comments

Use the Comments tab to add comments and send notifications to your team members. Comments can be used to discuss and clarify details or a particular design item during its life cycle. Emails notifies comment authors about replies, upvotes and mentions. Comments are only available in the Aligned Elements web client.

What's Changed

  • Important fixes regarding risk handling, Word and merging

Upgrade now

With important improvements and a handful of fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 3 here.

April 21 2020

What's New

Aligned Elements V2.5 Service Pack 2 (2.5.307/109.16875) is here and includes several integration improvements and a number of fixes. 

 

Enterprise Architect Integration

Leverage the powerful System Integration models of Enterprise Architect in your Aligned Elements traceability! Enterprise Architect Diagrams can now be part of Aligned Elements item through a live connection with the Enterprise Architect repository enabling both traceability between Design Controls in Aligned Elements and models in Enterprise Architect diagrams as well as incorporation of EA diagrams in Aligned Elements bi-directional Word reports.

 

Enterprise Architect

 

Integration with Redmine 

Use Aligned Elements integration with the popular Redmine ticket system to integrate Redmine tickets into your Design Control traceability. Create Redmine tickets from Aligned Elements on the fly when bugs are found during test execution, let Aligned Elements inconsistency checks validate the state of your Redmine items and use Aligned Elements bi-directional Word Integration to incorporate Redmine ticket into your DHF documents. 

 

redmine

 

Web Client Improvements

We have made a number of usability improvements available in the Aligned Elements Web Client to make your work easier and faster. These include displaying chapter structure in Trace Dialogs, one-click 'Add to Review' action from several view, single click 'Save document as PDF',  'Find In...' functions to locate Design Control Items in different contexts, Excel exports from tables and much more.

 

Trace To

 

What's Changed

  • Integration with Peforce Jobs
  • Use Test Runs without Configurations
  • Single click to find items in Trace / Project Explorer, Files and Test Runs
  • Compare Word documents using Words Document Comparison feature
  • Save Files in their folder structure to disk
  • Convert files to PDF at save to disk
  • Do risk reduction in Hazard Analysis and not in Mitigations
  • Make Unlock Objects a separate user right
  • Save tables to Excel (Web client)
  • Revert to Revision (Web client)
  • Save Trace Table as word template (Web client)
  • Add to Review from several views (Web client)
  • Display items in chapter structure in Trace dialog (Web client)
  • Create Harms and Mitigations on the fly (Web client)
  • Optional mail invitations sent from Review and Signature (Web client)
  • Support for table operations in Table attribute (Web Client)

Upgrade now

With important improvementsand a handful of fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 2 here.

February 27 2020

A smoother and faster IEC/ 60606-1 experience with Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist

The IEC/ISO 60601-1 "Medical electrical equipment" is the cornerstone document addressing many of the risks associated with electrical medical equipment.

The standard covers safety and performance requirements of medical electrical equipment and public health authorities in many countries recognize it as a pre-requisite for the market access. The standard is notorious for its depth and complexity and many manufacturers experience the task of ensuring compliance as challenging.

The safety testing, certification and global market access approvals done for IEC 60601-1 shall be conducted by an accredited Testing Lab. The manufacturer's collaboration with the Testing Lab is essential for a smooth and swift approval.

As of the 3rd edition of IEC 60601-1, a large number of risk management references were introduced in the standard. The Test Laboratory will request the manufacturer to demonstrate how the product's risk assessment covers the risks items stipulated in IEC 60601-1.

Poor preparation of this step can result in can delay the certification process, requiring an inordinate amount of time during the initial testing phase to correct the risk management files.

IEC60601

To facilitate this step, Aligned has developed an integrated assessment method in Aligned Elements, that assists the manufacturer in demonstrating compliance with these risks.

By assessing and connecting the IEC 60601-1 risk requirements with the product risk assessment already existing in Aligned Elements, a compliance assessment document can be automatically generated and presented to the Testing Lab.

Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist - How is it done

  • The checklist contains approx. 80 risk checklist items from IEC 60601-1 which are imported into Aligned Elements.
  • Each IEC 60601-1 risk checklist item contains the clause reference, the demonstration requirement, explanations and examples of what the risk intends to cover, all to facilitate the identification of the corresponding risk in the manufacturers risk assessment, already located in Aligned Elements.
  • The manufacturer addresses each risk requirement, deeming it either as "not applicable" for his product (including providing a qualification for the answer), or applicable and then tracing the risk requirement to the corresponding existing risks in his own risk assessment.
  • When completed, a Compliance Assessment Word Report is generated and can be presented to the Test Laboratory.
  • With this compliance report, the Test Laboratory representative can quickly assess your IEC 60601-1 risk related complicance level

The benefit of the Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist is a massive reduction of time spent at the Testing Lab by leveraging your existing documentation!

IEC 60601 1 Checklist

How we developed the Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist

The Aligned Element IEC 60601-1 Risk Assessment Checklist has been developed in collaboration with former Eurofins Electrosuisse Test Laboratory Manager Karim Bader, currently serving in the swiss national working group CES/TK 62 for "Elektrische Apparate in medizinischer Anwendung" contributing to the development of the international standard IEC 60601-1.

Experts from Aligned will assist you in integrating the checklist into your current configuration and demonstrate its use.

If there is a need to further explain the IEC 60601-1 risk management requirements and identify findings that can be fixed, Mr. Karim Bader, an expert in this field is available to deliver the knowledge and confidence to ensure that your product will be certified without delay.

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. to receive a quote for the IEC 60601-1 Risk Assessment Checklist.

December 12 2019

Sometimes I get the question "So how much time and money will I save by using Aligned Elements?"

A fair question and a question I can answer with a clean conscience: on average, you will save 30% or more of the time you currently spend on design documentation.

However, some medical device manufacturers can save (and have saved) a lot more than that!

If a modular documentation approach is applied, where reuse of already existing Design Control data is leveraged, there are examples of savings on up to 80%.

In this video below, you can find out more about the possibilities, prerequisites and benefits from Modular Design Documentation with Aligned Elements.

Happy Holidays!

Modular Design Doc Video

 

September 23 2019

What's New

Aligned Elements V2.5 SP 1 is a service pack consisting almost exclusively of bug fixes. 

What's Changed

  • Web Client optionally authenticates against Active Directory
  • Improved security mechanisms in Web Client
  • Improvements for Linked project handling in Web Client
  • Fixes in the Web Client Word Document Handling

Upgrade now

With important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 1 here.

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