Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

April 07 2019

 

Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station


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Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

The way to MDR: real world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval is more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as the costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and show possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hand-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Andrea Biasiucci, Senior Consultant, Confinis AG


Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

REGISTER NOW!


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

HWSMap

 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

March 22 2019

Reuse. Automation.
Two words we really like.
You should too, since they mean less work for you!

Robot

In this spirit, we created the Aligned Elements Automation Tool to speed up your Medical Device documentation work.

Aligned Elements - configured to match the manufacturer's QMS

But first, let's take a step back.
As you might know, the way a Medical Device Manufacturer's compile their development documentation is largely defined in its Quality Management System (QMS).
The QMS defines the processes, SOPs and templates used to design and document compliant medical devices in the most efficient manner given the manufacturers unique situation.

We go to great lengths to adapt and configure Aligned Elements to each customers QMS.
The result is a unique configuration that helps the manufacturer to write consistent, complete and compliant Design Control Documentation with minimal effort.
The configuration defines things like:

  • Consistent naming of all Design Controls
  • Customizable Quality Control checks
  • Flexible Risk Assessment parametrization
  • The Expected Traceability and rules to detect deviations
  • Customer specific Report Designs

Each time a new Aligned Elements project is created, the configuration makes sure that the created content is structured and aligned with the manufacturers QMS.

Reusing existing content

However, when documenting a device, it often turns out that much of the created content itself has potential to be reused in other projects.
Moreover, if established content is used uniformly across all device projects, a higher degree of consistency is established.
Such content can include:

  • Standard Design Control Items
  • Chapter structures
  • Trace Tables definitions
  • Frequently used Queries
  • Dashboard setups
  • Chart settings
  • Project settings like E-signature preferences and Email SMTP settings
  • Users and User Groups

Automated Reuse

These things have always been reusable in Aligned Elements With the Aligned Elements Automation Tool, it is now possible to transfer these settings to new and existing projects with a single click.

Setting up a new Aligned Elements project containing your company's established best practices is done within seconds!
The Automation Tool is the best way to swiftly leverage existing content in a consistent manner and shorten the project setup time to an absolute minimum.

So how does it work?

The Automation Tool combines a number of action steps in a single xml file and executes these actions against a selected set of projects.

Automation Tool

Multiple actions against multiple projects are performed in a single session.

The Automation Tool is installed as a Windows Application for manual use, as well as a Console application which can be used and triggered from other programs. 

Note! The Aligned Elements Automation Tool levereges the Aligned Elements REST API. Deploying the Aligned Elements Web Application is thus a prerequisite to use the tool.

The Aligned Elements Automation Tool can be downloaded here.

February 08 2019

What's New

This service pack contains an assortment of small to medium improvements. As always, it is based on a significant amount of input from the Aligned Elements User Community. The strongest focus is on improvements in the user management, web usability and Word reporting.

 

Improved User Handling

Collaboration with development partners in Aligned Elements is definitely something that will speed up your documentation work. But sometimes, some functions and data should stay off-limits for your partners.
With improved access management, Aligned Elements restricts access to functions and data and ensures that information is shared on a need-to-know basis. Optional log-in with Microsoft credentials is also possible, as well as optional display of full name and/or email of users wherever user actions are displayed.

 

User Groups

 

Inline Editing in Tables

The Aligned Elements Web client now supports inline editing in Design Control Items tables. This greatly improves usability as the Items don't have to be accessed individually for editing. A set of Items is opened for editing in table mode with a single click. Select the attributes to be displayed in the table, edit as you like and save all items with a single click.

 

InlineEditing

 

Word Improvements

Aligned Elements now optionally keeps track of Design Control Items inserted as Queries, Risk Tables and Trace Tables and will highlight any outdated documents where the items have changed after they were placed in the document. More flexibility in handling Word Template variants and enhanced coloring of Risk Assessments are welcome contributions from our users.

 

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What's Changed

  • Automatically add new Items to active Tags
  • Test Runs - Automatic removal of old attachments and issues at re-execution
  • Test Runs - Assign failed tests to new Test Run
  • Project Search Bar in Open Project Dialog
  • Generate, copy or execute multiple items in a single action
  • Signature stamp improvements now includes time and time zone information
  • Set Traces to existing items in Table Attributes
  • Import / Export of Project Settings
  • Synchronized import without synchmap files

Upgrade now

With important fixes and a handful improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 6 here.

December 13 2018

 

Finally! State-of-the-art Medical Device IT Security Requirements! And they are free! And you can download them!

For those of us who (in vain) have poured over IT Security standards and guidelines of variable quality in order to distillate useful requirements: look no further! A state-of-the-art, useable Medical Device IT Security guideline is finally here!

The Johner Institute has in collaboration with TÜV SÜD, TÜV Nord and Dr. Heidenreich (Siemens) compiled an excellent set of Medical Device Cyber Security Process and Product requirements and made it available to the industry for free.

Roughly 150 IT Security requirements are available in the Guideline covering both process requirements as well as product requirements, including the level of expertise needed to implement them, are available in the following structure:

Process requirements

Requirements for the development process

  • Intended purpose and stakeholder requirements
  • System and software requirements
  • System and software architecture
  • Implementation and development of the software
  • Evaluation of software units
  • System and software tests
  • Product release

Requirements for the post-development phase

  • Production, distribution, installation
  • Market surveillance
  • Incident response plan

Product requirements

  • Preliminary remarks and general requirements
  • System requirements
  • System and software architecture
  • Support materials

This IT Security Guideline is directed to Medical Device Manufacturers as well as Auditors, Reviewers and Hospital Management.

Dr. Johner and his collaborators have in this guideline managed to deliver concrete, best-practice guidelines, something that most other standards and regulations certainly tend to lacks.

Patches

The entire guideline is available in the GitHub-Repository „IT Security Guideline“ (https://github.com/johner-institut/it-security-guideline/) and is a recommended read for everyone concerned with Medical Device cyber security. You can also download Excel files with the requirements from the Johner Institute website.

We have made the Product IT Security Requirements available as downloadable extension for Aligned Elements. It is recommended to use them in conjunction with the material in the mentioned GitHub-repository, which contains valuable additional information and footnotes that explains the rationale and context for some of the requirements.

 

November 26 2018

Risk Assessments play a central role in Medical Device development. All medical device manufacturers apply risk management (they should because they have to!). All of them claim to be compliant with ISO 14971. And all of them do it differently.

I have worked with a large number of clients and I have seen more Risk Assessment variants than I can count. Some are good, some have, let's say, "potential".  

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From this experience, I can deduce a few best practices that will reduce the risk assessment effort considerably.

Here are my top five tips:

Don't brainstorm to identify risks

You are required to identify and assess ALL potential risks. How do you find them ALL? That can be a daunting question for someone new to the medical device industry.

However, the solution is to be structured i.e. to use a structured approach to systematically identify risks. There exists several known methods to do this, including:

  • Task Analysis (analysing the use process)
  • System Analysis (analysing the system through decomposition)
  • Using the ISO 14971 annex questions
  • Using existing risk reports of similar devices

Regardless of the approach selected, brainstorming should not be one of them. There are a number of well-known reasons for this, the most important one being that you will miss important risks.

Next time around, try a structured technique. You will identify more risks. I promise.

Use both top-down and bottom-up Risk Assessments

Some companies rely on EITHER bottom-up OR top-down risk assessment techniques and miss out on the fact that both approaches deliver vital and often DIFFERENT risks.

Top-down risk assessment techniques (such as PHA or Task Analysis) can be done early in the development process without much knowledge about the actual design of the device. It is a great tool for early identifying use errors and probably misuse.

Once the device design is known, the selected design itself must be analysed for risks (such as materials used, geometry, movements and energy emittance etc.) through a bottom-up risk assessment. FMEA's are very popular and well designed for this purpose. Both these techniques complement each other and should be conducted by any serious medical device manufacturer.

Don't keep Design Controls and Risk Management in separate systems

Design drives risk. And Risk drives design. This will become apparent when you need to follow up on the implementation and verification of mitigations as well as the further analysis if mitigations introduce new risks. The glue between the design and the risks is the traceability. The effort of managing this traceability in a paper-based documentation system will be VERY high (those of you who have done it will nod now!).

So is applying software tools the solution? Not necessarilly, since proper traceability monitoring can not be done until the requirement management tool is integrated with the risk management tool (or vice versa). Only by automatically managing the traceability between the Risk Assessment Items and the Design Items, preferably in a single tool, can true trace monitoring be obtained.

Use reasonable probability and severity scales

I am glad to see a clear trend of tightening down the probability and severity scales during the risk evaluations. From previously having used up to 10 steps, the current trend tends towards five to six steps or less. People simply have a very hard time to judge whether a probability should be six or seven on a 1-10 scale and spend too much time pondering such questions. The option range is simply too large to be effective!

For the probability axis, I would like to endorse Dr. Johner approach of having each step representing 2 orders of magnitude. He explains this very well by saying, that apart from such a an approach lets the probability axis span over more than 8 order of magnitudes, "...the factor 100 indicates the precision which we can appreciate... If you ask a group of people, how long it takes (on average) for a hard disk to be defective, the estimates vary between 2 years and 10 years. But everyone realizes that this average is greater than one month and less than 10 years. And between these two values is about a factor of 100."

Make use of existing mitigations

In many cases, the risk assessment is carried out when the design is already known. In such cases: when coming up with mitigations for your identified risks, use the already existing mitigations in your current design!

I bet your current design already contains a whole bunch of design decisions that are risk mitigations without you really considering them as such. The absolute majority of design teams I have encountered are very, very good in designing innovative and safe devices. However, many of the design decisions taken are based on previous experience, industry state-of-the-art, or simply old habits having been refined over time. Since these engineer are often better designers than document writers, they simply do not see their design (often already in place) through the lens of risk management.

Bottom line: your current design already contains of an uncovered treasure of existing mitigations. Try to use your existing design as mitigations when performing your next risk assessment.

Aligned Elements, our medical device ALM, assists you in performing structured risk assessments. Its highly customizable risk assessment configuration can be set up for a large array of risk analysis variants. Should you be interested in a demonstration, contact us on This email address is being protected from spambots. You need JavaScript enabled to view it.

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