Your medical device has been authorized and you have successfully placed it on the market together with the necessary technical documentation. However, time does not stand still – you have to demonstrate compliance with the regulatory requirements even post-marketing. For this reason, the technical documentation for medical devices requires ongoing revision each time the product evolves or is modified.
During this process, it is important for documents that refer to, and in part build on, each other not just to be up to date but also to be consistent – there must not be any discrepancies between them. It is for this reason that a medical device manufacturer has to appoint a Responsible Person, who has responsibility for the drawing up and also the updating of the technical documentation on medical devices in compliance with the MDR/IVDR. The Responsible Person has the task of 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 followed:
- MDR/IVDR
- DIN EN ISO 13485
- DIN EN ISO 14971
- DIN EN 62366
- DIN EN 62304
- DIN EN ISO 15223-1
Finding the necessary capacity and expertise for this in-house and ensuring that the process runs smoothly and swiftly are a major challenge. However, there is an easier way: Simply entrust our well-versed team of experts with handling all the updates to your technical documentation centrally. This will guarantee 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 in conformity with the MDR and IVDR
When you update your technical documentation, a great deal needs to be taken into consideration to comply with all the 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 are best advised by an experienced partner who can guide you through the whole process. Our finely tuned team of experts will take all over all steps as well as the whole coordination. From contact with the authorities to necessary adaptations to your medical device technical documentation to translation into the requisite languages.
Everything under one roof. Everything from a single source. So that everything is just right.
One contact person+the right team
With mt-g, you have a single contact person who coordinates everything, supported by a team of experienced experts. We take not only the work but also the coordination off your hands so you can rest assured that your technical documentation always meets all the requirements of the MDR/IVDR.
Up to3months sooner
Our well-versed experts specialize in technical documentation for medical devices. They know their stuff and are always up to date. The synergist effects within the proven team combine to help you reach the goal much much faster.
Your staff arefreefor other tasks
Your employees are highly qualified and busy. Taking them off other projects often leads to delays and disrupts important flows. We can take the whole project off your hands so that your in-house team members can concentrate on their own tasks.
Review byindependentexperts
The new regulations stipulate that the technical documentation always has to be reviewed by independent experts. Finding and consulting them is mostly a laborious step. At mt-g, we relieve you of these preoccupations, too, and have your documentation checked by the appropriate experts so that all the stipulations of the MDR and IVDR are fulfilled.
Services at a glance
Contact with Notified Bodies and potentially with other authorities takes time. Questions about the allocation of your products into the correct class also have to be clarified promptly. As an external service provider, we take on the contacting, planning and overall execution.
The new medical device regulations, the MDR and IVDR, stipulate exactly what the technical documentation must contain. Furthermore, the standard DIN EN 13485 also regulates the document content. Different requirements apply to medical device manufacturers and distributors. Without the necessary experience, it is not easy to interpret and implement these complex specifications product- and situation-specifically. Our adept expert advisers will help you make the right decisions and take the work off your hands.
Part of the conformity process for medical devices to achieve the CE marking is an independent, objective evaluation of the clinical data, before authorization as well as regularly postmarketing. In addition, planning, implementation and documentation system must be created for proactive market observation. Medicinal products must be continuously monitored for adverse drug reactions to guarantee drug safety.
Good quality management is essential for compliance with the new MDR and IVDR legislation. We can draft and revise your QM manual, help you to implement your quality guidelines, assist you with developing and/or checking master documents, checklists, flowcharts, standard operating procedures (SOPs) and carry out the appropriate corrective and preventive actions (CAPAs) for the continual improvement of your processes.
Risk management to minimize health risks is mandatory for medical devices and also 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 of the steps in the process off your hands and guide you from risk analysis and risk assessment to documentation and market observation.
Make the most of our experience
We can guide you through every step of the process.
Everything under one roof
All strands come together here
Adapting your documentation to fulfil the requirements of the MDR and/or IVDR takes teamwork. We will put together just the right team of up to ten experienced experts for you. What is particularly convenient for you about this is that you always have just one contact person, where all the strands converge.
Time is money
Ready three months sooner
We have the right experts on hand to bring your project rapidly to a successful conclusion.. This saves you the effort of searching for the right experts. Thanks to optimum coordination, we can handle your adaptation projects in finely tuned teams with the necessary human resources to be able to complete them up to three months sooner without frictional losses.
Take the burden off your staff
Your employees have enough to do.
They are needed in the business. Additional one-off projects such as these are drains on time and energy, while stress and overwork are known to be detrimental to morale at work and to staff retention. It is far more efficient to have your MDR and IVDR adaptation projects handled by our well-versed professionals. They have the necessary routine, not only saving you time, energy and resources, but also promoting harmonious teamwork within your company. From contact with the authorities to updates, from expert reviews to translations, we can take this all off your hands. So that your in-house team keeps at it and on the ball.
Review by independent experts
All requirements fulfilled
Independent experts always have the last word on the technical documentation under the EU Medical Device Regulation (MDR) and the In vitro Diagnostic Regulation (IVDR). We have the right experts for your project on hand. This saves time and money, and you can rest assured that all of the requirements will be fulfilled.
Updating technical documentations
according to MDR
The updating of your medical device technical documentation does not have to be complicated, protracted and laborious. You can trust mt-g – you will be saving time and looking after your staff while we handle your project reliably from A to Z and bring it to fruition.
