Learn how to safely pass the medical device approval process

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Introduction
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Prof. Dr. Christian Johner
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Quality Managers, Developers, Usability Engineers, Regulatory Affairs Managers, Risk Managers, Project Managers
Foundation
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veröffentlicht am 14.09.17
This short video training will give you an overview of the content of the technical file. You need this comprehensive file, in order to prove that your product complies with the essential requirements of the directives. This proof is a prerequisite, that you may declare the conformity of your medical device, by affixing the CE mark, and can start marketing your product.
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Start

This short video training will give you an overview of the content of the technical file. You need this comprehensive file, in order to prove that your product complies with the essential requirements of the directives. This proof is a prerequisite, that you may declare the conformity of your medical device, by affixing the CE mark, and can start marketing your product.

Essential Requirements

For the software the most relevant essential requirements are risk management, software life cycle and usability. Exactly these requirements – together with some others – define the content and even the structure of the technical file also referred to as technical documentation.

Risk Management

The risk management file consists – among others – of:

     

  • the intended use description,
  • a document or chapter explaining the manufacturers risk policy,
  • the risk management plan
  • and then the core content of the risk management file, the “risk table” in quotation marks. This table lists all risks and links it to the measures for risk mitigation. We recommend giving explanations and rationales to this risk table in a separate file, which could be a word document. Even better than stretching standards office packages over their limits, are dedicated tools as RiskPack from Medsoto.
  • The risk assessment matrix, actually these are two matrixes, summarize the risks pre and post risk mitigation, and a final statement justifying the acceptance of risks completes this file.
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Now you have at least a rough idea what your risk management file should consist of. Please watch our dedicated training courses explaining step by step how to write these documents.

Software

Software life cycle processes are mandatory. The documentation is most probably what you might expect: From software requirements to software architecture to code reviews to tests and to software release. Dependent on the safety class of your software you can skip elements, but in most cases this is what have to document.

Usability

To take the risks, which are associated with usability into account, is another essential requirement you have to fulfill. If you work according to IEC 62366 you will document – in addition to the intended use that we already mentioned – the main operating functions. You will specify the usability, possibly also by referring to style guides or to other standards, and you will plan, execute and document the usability verification and usability validation.

Product

So far we have had a slight bias to software. Obviously the specification, architecture and tests should not only be documented respectively performed for software but also for physical devices, as programmable electrical medical systems PEMS. If you document the PEMS architecture you will identify components, which are partially programmable electrical subsystems, the PESS.

Regardless whether you have a stand-alone software or any other medical device, you have to perform a clinical evaluation and provide information to your users e.g. in terms of user, installation and operation manuals.

Submission

If you plan to submit these documents you will include further documents like the certificates and list of applied standards, the classification, the declaration of conformity and if applicable FDA specific documents and statements.

Overview

All these documents constitute the technical file. However, this technical documentation is typically not the only thing you need:

QSR

Most probably you will have a quality management system according to ISO 13485 and/or 21 CFR part 820. This includes a description of your company, standard operation procedures, forms, templates and so on.

Watch our training courses to learn in details – step by step – how to write a technical file, how to establish a quality management system and how to successfully pass your audits.

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E-Learning Library: Become a member

A safe bet - not just in audits

The E-Learning Library will help you 

  • minimize embarrassing difficulties in the audit,
  • avoid wasting time and money on rectification (a re-audit will cost about 1,000 EUR, in addition to internal resources)
  • accelerate the process to the market for your product because you will avoid unnecessary project delays, e.g due to unnecessary rectification or elaborative (retrospective) development of your technical documentation. You would be surprised to know how much a project delay would cost you, try to divide your product revenue in a year into twelve, then you can see how much it already affects your monthly cost.
  • avoid expensive consultants and save your budget up to five-figures sum.

Your investment

Compared to how much all of these will cost you, auditgarant is an absolute bargain: just 990 EUR per year. We are convinced that it is almost impossible that this investment will not benefit you straight away. Convince yourself and order now!



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