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Technical Documentation

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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Software Documentation

Within a few days our experienced experts will help you to get your "software documentation" IEC 62304 and FDA compliant. We examine your situation and tell you exactly within two days what you have to do to document your software compliant with IEC 62304 and FDA requirements.

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Risk management File

Within a few days our experienced risk management experts will help you to get your risk management file ISO 14971 compliant. We evaluate your current documents and products  and tell you exactly within two days what you have to do to have an ISO 14971 and FDA-compliant risk management file.

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Clinical evaluation

We help you compiling a clinical evaluation that complies with European and US regulations and helps to quickly and safely get market approval for your medical device. We will study your clinical evaluation and tell you exactly in two days what you have to do to achieve compliance with regulatory requirements.

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Medical devices with artificial intelligence

The Johner Institute supports you as a manufacturer of products based on machine learning processes throughout the product life cycle.

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Get In Touch

Get in touch with us now so that we can design your lean QM system!

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Johner Institute helps you to compile these documents

No need to be scared! The Johner Institute is specialized to quickly and cost efficiently compile and review these documents. 

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?