Technical File: The precondition for market approval
Medical device manufacturers have to prove compliance of their products to US and European authorities (FDA respectively notified bodies). They have to submit an extensive technical documentation, also referred to as the technical file, that includes documents such as
- Device description
- Instructions for use
- Description of intended use / purpose
- Stakeholder requirements
- Product requirements and specifications
- Architectural design charts, construction drawings, circuit board layouts
- Software file including software requirements specification, software architecture, software detailed design, software unit, integration and system testing (plans and results)
- Risk management file including risk assessment, risk policy, risk analysis, risk mitigation
- Usability / human factors engineering file e.g. use specification, usability specification, use scenarios, formative and summative testing (plans and results)
- Clinical evaluation
- Product classification
- Declaration of conformity
- and much more.
Does this list rather scare you?
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All of Johner Institute's customers (these are hundreds) passed passed the approval process including audits, inspections and submission in the first shot. Want to learn more? Just contact us!