Content Technical Documentation
What documents you need
The list of documents you need depends on:
- the country in which you want to market your medical device
- the type of device (e.g., medical device versus in vitro diagnostic device)
- the class of the product (e.g. I, IIa, IIb, III)
- the product category
- the selected technologies and materials
Typically, technical documentation includes the following documents or files:
- Intended Purpose
- Stakeholder and system requirement specifications
- Design drawings
- ISO 14971-compliant risk management files
- IEC 62366-1 compliant usability file
- IEC 62304-compliant software development file
- Verification and validation plans and results. This includes electrical safety, EMC, and biological safety testing.
- Clinical evaluation
- Regulatory documents such as an MDR checklist, declaration of conformity, list of applied standards, justification for classification of the product.
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