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 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.

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