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Our Technical Documentation File Template is designed to grant you access to each section that must be present in your technical documentation. Gain precise insights into the contents of each section.
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To immerse you fully and ensure completeness, our experts have crafted a fictitious medical device: "HealthGuard BPX-2000". What better way to derive inspiration than from an actual medical device, tailoring it to your needs or those of your clients?
You will find concrete examples for each section, enabling you to optimize your writing to meet the requirements of your notified body or client. Craft your technical documentation to align with Annex II, ensuring that you strike the perfect balance in each paragraph—enough information without overwhelming detail.
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We've distilled the finest writing practices and incorporated all necessary sections to meet the demands of MDR 2017/745 technical documentation.
This template was crafted based on over 10 successful CE MDR submission experiences across various device classes, with renowned notified bodies.
"This will cut down on my RA's time to develop TFs for my clients under the eumdr. Thanks!"
"The template looks great, exactly how we expected!"
This template will allow you to:
✅Access a fully editable Word document (.docx) to facilitate your writing
✅Know precisely how to draft each section of your technical documentation
✅Have pre-written paragraphs and tables at your disposal for inspiration in crafting your device's documentation
✅Bring clarity to your technical documentation
✅Benefit from the experience of over 10 CE MDR submissions
✅Avoid going through endless and costly review rounds with your notified body
Benefit from real and concrete examples with a blue-print medical device
Compliant with annex II of (EU) MDR 2017/745
For each sections, find the perfect balance to describe your medical device.
Ready to use, you juste need to replace the information for your device
Benefit from the experience of over 10 successful CE MDR submissions.
A template designed by experts, for experts. Our promise, a template that ensures compliance.
