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

September 16 2016

The 2016 "Documentation Trends and Insights in Medical Device Documentation" survey is live!

Are you alone in experiencing challenges when it comes to Medical Device Documentation? Or is what you feel shared by the industry?

Man with papers

We invite you as a Medical Device professional to share your thoughts on the state of documentation practices by participating in this survey.

The survey will assess how Medical Device organisations manage regulatory driven documentation challenges during the R&D phase.

Take the 2016 Medical Device Documentation Survey now!

August 24 2016

The imminent update of the EU MDR and IVDR regulations has serious effects on Notify Body access. The result might be an increase in company value of manufacturers for second-rate products.

Read the full article here.


July 06 2016

Not long ago I sat down and had a really good talk with Ilari Henrik Aegerter from House Of Test. Ilari has an extensive background in high-quality testing and is one of the leading opinion makers in the area of context-driven testing. Ilari is also a strong advocate of Exploratory Testing and I challenged him to explain how Exploratory Testing could fit into the world of strict and regulated medical device development.

"One way of thinking about testing is value creation. Value is created by increasing the knowledge about the system.” starts Ilari, “Through testing, you gather information about your system’s desirable and undesirable behavior. Now, some testing methodologies accomplish this more efficiently than others.”

"In traditional, scripted testing, the task is to verify that the system behaves according to a formally specified input, a.k.a "confirmatory checking". I see this approach a lot in the medical device industry, often accompanied by extensive documentation, meticulously describing the input and output.” 

“The drawback of this approach is that it only traverses a very narrow path of the system. The generated results is equally meager when it comes to unveiling previously unknown knowledge about the system. It also abstains from tapping into the creativity and system expertise of the tester. 

Let me make this clearer with an illustration.”


“This diagram describes a medical device. As you can see, we have three ways of looking at the product:

  1. The User Needs: this area represents the features set the customer actually wants.
  2. The formal Specifications: this area is made up of the Design Controls, where the manufacturer attempts to formally define the system he is planning to build.
  3. The actual Implementation: this final area represents the feature set the instrument actually supports 

In the ideal case, a medical device is characterized by perfect intersection between all three areas.

Now, let's evaluate what happens when this is not the case.

"Specified but not implemented" - This area translates to turn up as failed tests in the medical device documentation, something that becomes accentuated in companies that focus on verifying formal specifications. Not uncommon in the medical device industry.

"Implemented and specified but not covered by User Needs" - Sometimes called "Gold Plating". From a scripted test perspective, this area is going to transform into passed test cases. One might question the value of implementing things that the Users don't need, but there might exist business reasons that explains this area.

"Implementation and User Needs intersect but are not covered by Specifications" - This is the result of an experienced developer who knows what the User Needs even though it is not specified. Unfortunately, this part is not going to be covered by the formal verification so we can only hope that the implementation actually works.

Finally, the most important area is represented by the "unmet User needs". This area is going to come back as bugs and change requests in the post-market phase. Despite having done the things right, we have apparently failed to do the right things. Some of these user needs might have been explicitly left out for cost reasons or with the intention to be implemented later. However, the critical part consists of the "things we didn't think about".

And voila, here is where exploratory testing can make a big difference. By applying a broader testing mindset, not being constrained by the narrow path of formal specifications, a wider test coverage is reached and more knowledge is obtained about the system. More knowledge is more value. The best part is that studies have shown that exploratory testing is much more efficient in finding bugs per time unit compared to traditional testing."

At this point, I asked Ilari if these unmet User Needs would not be uncovered during the Design Validation? Wasn't this exactly the objective of validation, to check that we have done the right things? 

"Partly", says Ilari, "the notions are related but not the same."

“In recent years, we have seen an increased focus on usability and human factor engineering in medical device development. We have also seen an increased regulatory focus on performing proper validation for each new release. The whole point of these disciplines is to engage the user perspective, since the user probably knows more about the final usage than the manufacturer. Usability and human factor engineering are valuable tools to emphasize, charter and corroborate user needs in the design process.

Exploratory testing is focusing on similar issues. It leverages the creative and critical thinking of the tester, mimicking the thought process of a user. It challenges the tester as a domain expert and explicitly attempts to uncover tacit and unspecified needs."

I was still skeptical. "But, Ilari, we still need to be compliant with the FDA. We still have to show that the specifications are met and we still need to have documented proof. Exploratory testing makes a big point how traditional, scripted testing is obsessing about repeatability and documentation, indicating that these are not important steps." 

"That is not true.", Ilari responds, "I think this is a misconception about exploratory testing, i.e. that it does not test specifications and does not produce documented evidence. Of course exploratory tests are documented. It's just that it might not use the same level of detail and that it better highlights undesired behavior, instead of only focusing on meticulously writing down everything that works as specified.” 

“My opinion is that exploratory testing generates more knowledge about the system. This is particularly valuable during the early development stages. If you have worked in the industry, you know exactly what I am talking about. At this stage, the specs are constantly changing, the device is continuously modified, a lot of factors have not yet stabilized and it is simply not efficient to start writing formalized test scripts at this point. During these phase, exploratory testing is the superior testing method for generating knowledge about the current system state.” 

“This idea is partly reflected in the FDA document Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff”. The document states that an exploratory studies in the early, and even pivotal stage of a clinical investigations, is advantegous, simply because it generates more knowledge about the system. In this line of thought, exploratory testing does not replace scripted testing, but certainly precedes and complements it.”

I must say that Ilari is building a case here. We leave the discussion at this point, both excited about the prospects and challenges of exploratory testing in a medical device context.

July 01 2016

Documenting the design controls for a medical device is a mandatory exercise in our industry. Regulations descibe what the documentation must show. Standards describe harmonized ways in which regulations can be fullfilled. Your quality management system should, in best case, describe which process you need to follow in order to satisfy the standards and regulations and finally your company templates are what you use to finally pen it down.

However, regardless of the multitude of support systems, at the end of the day some of us given the task to provide a document, will sit down in front of the computer and think: 

But what exactly should I write?

Here is where we can help. The Aligned Elements Extension section contains more than 50 importable plug-and-play content packages that can help you accelerate the documentation process by leaning on collected experiences and best practices. Our extensions examplifies how Aligned Elements can be used to solve ubiquitus medical device documentation problems.


These extensions contain things like:

  • Example Design Controls such as 21 CFR Part 11 Requirements, ISO 14971 Harms etc.
  • Ready-made configuration packages for e.g. IEC 62304 and IEC 62366
  • Regulatory Wizards, such as finding out if your software is a medical device
  • Queries
  • XSLT - transformations to transform Aligned Elements into a desired output format

To make this even better: all extensions on our website are free to our customers.

Today, we added a new package of 120 Infusion Pump requirements examplifying the Design Input for an Infusion Pump device. Let us help you. If you have questions about our extensions, please This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

June 17 2016

In the beginning of June, MHRA has release its guidance Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products. It is meant to help Medical Device manufacturers in the areas of human factors and usability engineering and clarifies the expectations of the notified bodies around compliance with the EU medical device legislation.


The content is to a large extent a reiteration of IEC 62366-1:2015. In any case, this is yet another indication of the increased focus involved agencies place on Human Factors and Usability Engineering.

Should you be interested in finding our more about how Aligned Elements implements IEC 62366-1:2015, click here.

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