Aligned AG - IEC62366

Medical Device Documentation: but what (exactly) shall I write?

Documenting the design controls for a medical device is a mandatory exercise in our industry. Regulations describe what the documentation must show. Standards describe harmonized ways in which regulations can be fulfilled. Your quality management system should, in the 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 exemplify how Aligned Elements can be used to solve ubiquitous 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 the 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 exemplifying 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.

MHRA releases Guidance on Human Factors and Usability Engineering

In the beginning of June, MHRA has released 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 out more about how Aligned Elements implements IEC 62366-1:2015, click here.

Take Usability Engineering seriously!

"Dexcom has announced a massive and serious continuous glucose monitors recall, involving more than 260,000 devices with alarms that may fail to sound."

Not hearing the alarm of a medical device is not a good thing. When should the manufacturer have picked up on this? During the usability validation at the latest.

Underestimating usability engineering and proper usability validation can have serious consequences (obviously). Still, usability engineering is still in many places regarded as an outsider practice by many "regular" engineers, considering it being a discipline about "taste". I assure you that this is not the case.


There is tremendous potential in applying usability engineering during product development. Standards covering usability and human factors design such as the IEC 62366-1:2015 address the potential risks of poor usability design. However, being compliant with these standards will not only make the medical device safer. They also make the product easier to use and thereby creates more value for the users and patients. 

To make the documentation of the usability engineering tasks faster and easier, we have added a preconfigured IEC 62366-1:2015 setup to Aligned Elements.

The Aligned Elements IEC 62366 Usability Configuration

With the 2015 update of the IEC 62366-1:2015 and the issuing of the FDA  Human Factor Guidance, usability engineering in medical device development has received increased attention recently.

Human factor analysis gets more important with the rising trend of offering patient-centric solutions via new mobile health applications and wearables.
When patients, rather than specialists become the medical device user, the increased focus needs to be placed on the patients' capabilities and the environment in which the device is used. IEC 62366-1 is applied in an effort to increase patient and user safety by identifying, assessing, and mitigating Use Errors, by paying attention to the usability of the device design and harness existing usability verification and validation methods to make sure that usability requirements are met and use errors are avoided.


For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Element now features a preconfigured setup that integrates the inputs, outputs, and risk-relevant elements of the usability process into the overall Design Control traceability.

The configuration includes:

  • 8 Design Control templates for capturing the input and output elements of the usability process
  • Pre-configured content validation checks assessing the consistency of the project in real-time
  • ISO 14971 compliant risk management to identify, assess and mitigate Use Error-driven risks
  • Interactive Checklist for reviewing the Use Specifications Document against IEC 62366-1:2015 
  • 20 usability example risks for Use Errors during the Transport, Storage, Installation, and Decommissioning
  • 2 preconfigured Traceability Tables
  • Integrated test protocols for established test methods such as:
  • Cognitive Walkthrough
  • Heuristic Evaluation (based on the Nielsen-Schneidermann heuristics)
  • Simulated-Use Testing for Usability Validation

On top of all that, the Aligned Elements IEC 62366 includes all the standard features of Aligned Elements, including:

  • Completed change control of all Design Control Items
  • Complete audit trail for all changes
  • Keep your company specific look and feel of all report outputs
  • End-to-end traceability with real-time impact analysis
  • Easy and fast Word reporting using drag and drop
  • FDA QSR 21 CFR Part 11 compliant User Management
  • Efficient decision-making process using workflows and E-signatures

By applying selected parts of the Aligned Elements IEC 62366-1 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62366-1 compliance effort.

The Aligned Elements IEC 62366 configuration is available for download in our extension library.

For a live demonstration of the Aligned Elements IEC 62366 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.