Regulatory Affairs

Regulatory Affairs

The qtec Aktenfuchs

Technical Documentation
for Medical Devices

qtec Aktenfuchs
Noun, masculine [the]

Someone, who knows the Technical Documentation for Medical Devices well, and who is willing to share this knowledge.

Do you want to get an insight?

Do you want to get an overview of your product file? Do you need support in structuring and planning? Here you can go directly to the online inquiry.

Application form

Your potential problem

Is your Technical Documentation for Medical Devices up to date? Technical Documentation for Medical Devices present the following challenges for small and large companies alike:

  • "Documenting" the Medical Device in all circumstances
  • Keeping the documentation up to date
  • Taking into account various country-specific and regulatory requirements
  • Documenting changes to the product during the entire life cycle
  • Strategic reorientation of the product portfolio
  • Illustrating the extensive range of variants and new production techniques

Are you still busy documenting?

On the one hand, the ongoing challenge is always documenting in sufficient detail to meet the requirements. On the other hand, staying concise, systematic and smart enough to maintain long-term care can also be difficult. All the while, it is easy to quickly lose track of what is going on and the documentation is no longer up-to-date.

Our solution

The qtec Aktenfuchs will burrow through your filing cabinet! In our Aktenfuchs program we combine many years of experience with

  • the efficient new creation
  • revision and adaptation/partial adaptation

of TD, DHF and DMR with the professional and flexible competence of a constantly growing team of Medical Device experts.

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60
 

We bring tidiness to your documentation

The qtec Aktenfuchs team will bring your documentation up to date in a two-step procedure.

  1. In a first step, depending on the complexity of your product/product family, an initial gap assessment is carried out by our experts with the help of systematic processes and checklists. The result is presented to you in the form of a gap assessment report.
  2. In a second step, we close the identified gaps in consultation with you and, for example, redesign the clinical evaluation, revise the risk analyses or restructure and update your verification evidence.

At the end of the process, we are happy to hand you the complete or partially updated parts of your documentation in a reproducible quality from an expert source.

Initial situation

Result

E1

GAP assessment was conducted

E2

CAP (Corrective Action Plan) was available within approximately 20 calendar days after the start of the review

E3

Aktenfuchs updates the TD during the project, taking existing documents into account

E4

The TD is submitted to the Notified Body according to Regulation (EU) 2017/745 and the product receives approval

Please ask us without reservation

Would you like to get an overview of your product file? Do you need support in structuring and planning implementation? Then you are welcome to contact us. We will support and advise you on your options without obligation.

    • Technical documentationThe technical documentation is the documentation according to Annex II and III of Regulation (EU) 2017/745 and (EU) 2017/746 respectively.
    • Development fileThe development file concerns the documentation according to EN ISO 13485:2016 point 7.3
    • Medical Device FileThe development file concerns the documentation according to EN ISO 13485:2016 point 4.2.3
    • Is there more information you would like to share?
      YesNo

    The effort of an evaluation depends on the extent of the documentation, the quantity of Medical Devices as well as their complexity. Therefore, the information given refers to the products that are part of the file(s) to be assessed:

    • How many products are part of the document(s) being evaluated? (Including variants)
    • Are these active products?
      YesNo
    • Are they Stand-Alone Software?
      YesNo
    • Are they invasive products or implants?
      YesNo
    • In which risk class are the products classified?
    • Are the products placed on the market in sterile condition?
      YesNo
    • Are the devices reprocessable?
      YesNo
    • Are the products equipped with a measuring function?
      YesNo
    • Are the products manufactured using organic materials, or do the products contain such materials? If so, which ones?
      YesNo
    • YesNo
    • You are welcome to provide us with additional information about your products, company, or product portfolio:


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