Your medical device has received authorization, and you have successfully placed it on the market together with the required technical documentation. But the clock keeps ticking – even after the product has been placed on the market, you must prove compliance with the regulatory requirements. For this reason, the technical documentation for medical devices (MDR) requires ongoing revision each time the product is updated or modified.
As part of this process, it is important that documents that refer to, and in part build on, one another be not just up to date but also consistent – there cannot be any discrepancies between them. For this reason, medical device manufacturers must appoint someone, who is responsible for drawing up as well as updating the technical documentation on medical devices in compliance with the MDR/IVDR. The responsible person is responsible for maintaining submissions and approving and incorporating updates.
This is more complicated than it sounds. The following are just some of the regulations that might need to be taken into account:
- MDR/IVDR
- DIN EN ISO 13485
- DIN EN ISO 14971
- DIN EN IEC 62366-1
- DIN EN IEC 62304-1
- DIN EN ISO 15223-1
Finding the necessary capacity and expertise for this in-house and ensuring that the process runs smoothly and swiftly is a major challenge. However, there is an easier way: Simply entrust our accomplished team of experts with the task of handling all updates to your technical documentation centrally. This will ensure the necessary consistency at all times, and you can relax, secure in the knowledge that everything is in experienced hands.
And that everything is just right.
Updates pursuant to MDR and IVDR
When updating your technical documentation, a great deal must be taken into consideration in order to ensure compliance with all provisions of the Medical Device Regulation (MDR) and/or the In Vitro Diagnostic Regulation (IVDR). This applies not only when the device is placed on the market, but also when there are modifications and updates.
You will receive the best advice from an experienced contact partner who can guide you through the whole process. Our finely tuned team of experts will take charge of all steps in the process as well as coordinating the entire process. From contact with the authorities to necessary adaptations to your medical device technical documentation to translation into the required languages.
Your one-stop language service provider. So that everything is just right.
Designated contact persons+the right team
At mt-g, you have designated contact partners coordinating everything, supported by a team of experienced experts. In addition to the work itself, we also take care of the coordination for you. This way, you can rest assured that your technical documentation will always comply with all requirements of the MDR/IVDR.
Reach your goal efficiently
Our highly experienced experts specialize in technical documentation for medical devices. They are deeply familiar with the matter and always up to date. The synergy within our proven team help you reach your goal even more efficiently.
Your staff arefreefor other tasks
Your staff are highly qualified and busy. Taking them off other projects often leads to delays and disrupts important processes. We can take the whole project off your hands so that your in-house team can concentrate on their own tasks.
Services at a glance
Contact with notified bodies and potentially with other authorities takes time. Questions regarding the allocation of your products to the correct class must be resolved promptly. As an external service provider, we undertake the contact, planning, and overall execution.
The new medical device regulations, MDR and IVDR, specify exactly the content of the technical documentation. Furthermore, DIN EN ISO 13485 defines the information that must be included in the documentation. Medical device manufacturers and distributors are subject to different requirements. Without the necessary experience, it is difficult to correctly interpret and implement these complex specifications as they apply to the respective product and situation. Our accomplished expert advisers will help you make the right decisions and take the work off your hands.
Good quality management is essential for compliance with the new MDR and IVDR regulations. We can draft and revise your QM manual, help you to implement your quality guidelines, assist you with developing and/or reviewing master documents, checklists, flowcharts, work templates, and standard operating procedures (SOPs), and carry out the appropriate corrective and preventive actions (CAPAs) for the constant improvement of your processes.
Risk management to minimize health risks is mandatory for medical devices as well as for the underlying processes, such as manufacture and placement on the market. These processes must be evidenced in the technical documentation. We can take some or all steps in this process off your hands and guide you from risk analysis and risk assessment right through to documentation and post-market surveillance.
Make the most of our experience
We can guide you through every step of the process.
Your one-stop provider
All strands come together here
Adapting your documentation to fulfill the MDR and/or IVDR requirements takes teamwork. We will put together the right team of experienced experts for you. To ensure that the process is convenient for you, you will always have designated contact partners, who will pull together the different strands of the project.
The right experts will see your project through to a successful conclusion.
Reach your goal efficiently
We have the right experts on hand to bring your project to a speedy and successful conclusion. This saves you the effort of searching for the right experts. Thanks to optimum coordination, we process your adaptation projects in finely tuned teams with the necessary human resources to complete them efficiently without frictional losses.
Take the burden off your staff
Your staff have enough to do.
They are needed in the business. One-off additional projects tie up your internal capacity, which could be better used elsewhere. It is far more efficient to have your MDR and IVDR adaptation projects handled by our highly experienced experts. They follow the required routine, saving you time, energy and resources as well as promoting goal-oriented teamwork within your company. From contact with the authorities to updates, from expert review to translation, we take everything off your hands, so that your in-house team is free to focus on other tasks.
Review by independent experts
All requirements fulfilled
The notified bodies always have the last word on the technical documentation under the EU Medical Device Regulation (MDR) and In vitro Diagnostic Regulation (IVDR). Depending on the medical device, notified bodies are supported by external clinical experts, expert committees, and national authorities, among others. We have the right experts for your project on hand. This saves time and effort, and you can rest assured that all the requirements will be fulfilled.
Adjustments to your technical documentation
according to the MDR
Updating your medical device technical documentation does not have to be complicated, time-consuming and tedious. You can trust mt-g – you will be saving time and spare your staff while we reliably handle every aspect of your project and bring it to a successful conclusion.
