Regulatory Affairs
The qtec Aktenfuchs
Technical Documentation
for Medical Devices
Noun, masculine [the]
Someone, who knows the Technical Documentation for Medical Devices well, and who is willing to share this knowledge.
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
Technical Documentation (TD)
Technical Documentation for Medical Devices for conformity assessment based on Annexes I, II and III of the Medical Device Regulation with the integration of optional parts for international approvals. A structure is shown in Annex II of the MDR.
Development file
Based on the requirements of EN ISO 13485:2016 and adapted to the requirements of the Design History File (US FDA) for use in both markets
Medical Device File
Based on the specifications of EN ISO 13485:2016 and adapted to the requirements of a Device Master Record (US FDA) for use in both markets
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.
Discover our "TrendReport" service
Full service for the reporting of trends in accordance with Art. 88 of the MDR. Learn more about TrendReport.
We will tidy up your documentation
The qtec Aktenfuchs team will bring your documentation up to date in a two-step procedure.
- In a first step, depending on the complexity of your Medical Device/Medical Device 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.
- 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
A1
Class IIb TD product in Q4 2019 with limited MDD conformity (Compliance Level 25%)
A2
TD only partially available in digital form
A3
Product should also be resold under MDR
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 Medical Device receives certification
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.
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