In order to comply with statutory requirements, all manufacturers require a technical documentation. This documentation must be fully updated at regular intervals. We can prepare everything you need for your technical documentation.
CE / Technical Documentation
Your technical documentation is the heart of your approval application. It combines information on the technical specification of your device with details of management, testing and assessment outcomes. A clear structure and precise language will ensure that your application is accepted by notified bodies, as well as by authorities in Germany and abroad.
We can make your life easier by compiling anything from individual documents to entire CE files for you, ensuring a safe product for market access.
General Safety and Performance Requirements (MDR Annex I)
All medical devices must comply with the general safety and performance requirements set out in Annex I of the MDR. It is the responsibility of the manufacturer to prove that their products meet these requirements. Fulfilling these requirements, some of which can be rather abstract in nature, and documenting your compliance can both prove challenging.
We can take on the challenge for you by identifying the action you need to take and drafting all the necessary paperwork, so that you can provide all the evidence you need.
Product information, warning notices and instructions for use are just some of the content that must be included by law in user manuals for medical devices. Standards and guidelines at both national and international level come with further requirements relating to the documentation accompanying medical devices.
If your user manuals and labels need to withstand the critical scrutiny of regulators, why not ask our experts to draft them for you?
The clinical evaluation is one of the most important documents you need when evidencing the benefits and performance characteristics of your medical devices. Drafting it requires specialist skills and a scientific mindset.
Our expert team of medical and technical specialists can draft up-to-date, technically appropriate clinical evaluations for all your devices.
The clinical evaluation is followed by post-market clinical follow-up (PMCF), an ongoing process that continues throughout the life-cycle of your device.
We take care of the planning and documentation, provide recommendations on action to take, and prepare updated evaluation reports to meet relevant deadlines.
The entry of a product into the market marks the beginning of post-market surveillance (PMS) for manufacturers of medical devices. As part of this process, data has to be gathered and evaluated from a range of internal and external sources.
The risk management file represents a further key document within your technical documentation. It needs to identify any risks associated with your device, set out any measures to minimise this risk, and provide evidence of how these measures will achieve the desired effect.
We can take over this complex process for you and prepare a complete documentation on your behalf.