Aligned Elements Product News

December 11 2020

 

Have you ever struggled to describe Hazardous Situations so it was clear to all stakeholders what you intended to say?

Did you spend a lot of time to come up with concisely written Sequence of Events and then the first person to review your document claims to not understand what you intended to convey?

When describing your harms, have you ever wished that someone had put together a list of all possible harms, so you could just pick the one, which is applicable for this particular situation?

And then after your product release, did a Risk occur that you did not foresee?

Common Terminology by curtesy of the IMDRF

If you have ever experienced one or more of the above, there might be some help out there. The International Medical Device Regulators Forum (http://www.imdrf.org) has created a document called IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes.

Although that is quite a mouthful, this document can make your life a lot easier. It provides an extensive list of possible medical device problems, possible harms and related causes. Each term is assigned a code, which have to used when creating a Manufacturer Incident Report as required by the MDR (https://ec.europa.eu/docsroom/documents/41681).

These codes can also be used when reporting Adverse Events to the FDA by means of a Medical Device Report (https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes).

Is the terminology only applicable for post-market events?

Although the terms compiled by the IMDRF have a strong focus on Post Market incidents, they are also useful in your pre-market design risk assessments. When performing your ISO 14971 compliant Risk Analysis during the development phase, a lot of time is (and should be) spent on the risk identification process to make sure all potential risks have been assessed and addressed.

In practice, this requires writing down and assess the hazardous situations, what causes and subsequent harms that could possibly arise by using your product. However, these are essentially the same as in a post market scenario. Using the lists provided by IMDRF can speed up this process significantly.

So how does this make things easier for me?

The IMDRF lists act as an acceleration vehicle for your Risk Analysis. By using and analysing these established terms, you will save a significant amount of time when documenting all possible hazardous situations, causes and harms. At the same time the likelihood of overlooking a particular hazardous situation, cause or harm is greatly reduced.

Furthermore, ambiguities are reduced by using and referring to an established set of risk terminologies. Thus, you reduce the risk that other stakeholders, not just your colleagues, but also the auditors, will not misunderstand your carefully constructed Risk Analysis.

Using the IMDRF terminology in Aligned Elements

The lists are applicable to Aligned Elements projects using Risk Assessments using the Preliminary Hazard Analysis method. 

It is possible to import the IMDRF items directly into Aligned Elements by using four import packages which you can download here.

The extension consists of lists containing a Design Control type called “IMDRF Item”, which have the attributes “Code” and “Definition”.

When importing them, you will need to map the types to types that exist in your configuration.

Note that the lists contains a large number of items which may not all be applicable to your particular device.

A pre-assessment step of the list content is therefore recommended before applying them into production projects.

The following mappings should be done.

  • “Annex A, Medical Device Problems” (469 items) should be mapped to a type which represents “Potential Hazards” in your configuration.
  • “Annex D, Investigation Conclusions” (35 items) should be mapped to a type which represents “Causes” in your configuration.
  • “Annex E, Health Effects - Clinical Signs and Symptoms or Conditions” (797 items) should be mapped to a type which represents “Harms” in your configuration.
  • “Annex F, Health Effects - Health Impacts” (64 items) should be mapped to a type which represents “Harms” in your configuration.


Please do not hesitate to ask for assistance at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

November 12 2020

Risk Identification is an early and essential part of the risk management process and ISO 14971 requires us to make a complete risk assessment, to identify ALL hazards. 

But, how do we know if all of the hazards have been identified? How can we prove this?

You could brainstorm or have a white board session gathering ideas that pop up, but the only way to truly achieve confidence in your risk identification process is by using a structured approach. 

There are several techniques available depending on the assessed source, including:

  • Assessing established potential hazards from internal records or published standards
  • Analysis of the manufacturer's experience with similar medical devices
  • Conducting a User Task Analysis on the user’s interaction with the device to uncover use errors
  • Assessing Field data and published incidents from similar devices in use
  • Assessing critical components for safe an effective use

Because of the difficulty involved with thoroughly identifying all of the hazards, ISO 14971 provides a number of aides – such as Annex C (2012) (becoming the ISO 24791 Annex A in the 2019 edition) – which provide a list of questions to assist in establishing device characteristics that may impact safety. Although not exhaustive, these question can serve as starting point and become of one of several potential approaches from which the complete risk identification can be assembled. 

Aligned Elements users can kick start their risk identification process by downloading and importing our ISO 14971:2012 Annex C Extension, assessing them and start generating risks and mitigation. 

The ISO 14971:2012 Annex C Extension contains:

  • RVT file for an ISO 14971 Annex C Question and a corresponding DOCX Reporting style template
  • 37 importable questions built on Annex C in ISO 14971 to assess and integrate in your Risk Assessment

This Extension facilitates the assessment of the questions, the creation of both an automated assessment report of the Annex C questions as well as a starting point for generating new risks and mitigation. 

It gives medical device manufacturers a predefined starting point when setting up their technical file with the intention of accelerating the documentation effort.

The user is of course welcome to expand this question list with questions that are particular for his/her device and the conditions under which it needs to operate.  

The ISO 14971:2012 package can be combined with other risk identification packages from Aligned or in-house developed approaches by the manufacturer.

The ISO 14971:2012 Annex C package is free to Aligned Elements users.

For more information on how you can include our ISO 14971 questions in your risk assessment, contact the This email address is being protected from spambots. You need JavaScript enabled to view it. today. 

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.

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