Regulatory Affairs
qtec CE-Med
MDR placement and growth acceleration for your products
The challenge for Medical Device manufacturers is increasing:
- The MDR requires a more extensive QM system, comprehensive post-market surveillance, and robust clinical evaluations.
- To refinance these high costs, more international growth is needed.
qtec CE-Med is the solution for MDR requirements and growth
Our qualified experts offer all necessary services to meet the regulatory requirements of the MDR and for the sustainable growth of your company. This applies to your entire Medical Device portfolio or just parts of it.
Regulatory Affairs and Quality Management
Growth
Regulatory Affairs for Medical Devices under the MDR
Our experts are well versed in the entire lifecycle of Medical Devices. This begins with requirements engineering and covers the areas of Risk Management, software quality, verification & validation, clinical evaluations and approvals, all the way to post-market surveillance. Strictly speaking, we are even able to advise and support companies beforehand - i.e. at the product idea stage.
As the original service provider for Medical Devices, we are specialized in placing Medical Devices on the market and are therefore in a position to assume the function of a legal manufacturer. In doing so, we approve fully developed products and bring them to the Medical Device market. If the administrative or cost pressure is too high, CE-Med takes over products from a certified OEM (Original Equipment Manufacturer) and has them certified for the market or pushes their development.
MDR challenge – increased scope and costs
With the Medical Device Regulation (MDR) coming into force in May 2021, the scope of the regulatory framework for the approval and monitoring of Medical Devices has expanded many times over. But not only have the regulatory requirements become more extensive, their costs have also risen significantly. For some manufacturers, it is simply not worthwhile to pursue the complex and cost-intensive approval path under the MDR. With CE-Med's support, these companies can once again focus on their strengths as manufacturers.
For which companies do we work successfully?
In general, CE-Med's services are suitable for the following companies:
- Companies within the EU with Medical Devices of classes1 and 2 a/b in their portfolio, which are burdened under the pressure of the requirements and costs of the MDR and which want to continue to distribute their existing products on the market. CE-Med manages these products and their regulatory responsibilities.
- StartUps with new products or product ideas which we support as Legal Manufacturer. In this case, we will take over the complete obligations and tasks for approval and placing on the market.
- Companies outside the EU that want to distribute their Medical Devices on the European market. As a distributor, we assume responsibility for the more extensive QM systems required by the MDR, comprehensive post-market surveillance and the preparation of reliable clinical studies.
Due to their daily contact to these kinds of projects, our experts are more than capable of taking on all tasks involved with the approval of Medical Devices and performing the necessary audits. CE-Med as part of the qtec group also assumes all duties as responsible manufacturer for market surveillance and monitoring to control incidents.
Growth for your business
In addition to the high level of expertise provided by our employees, we can also rely on an extensive distribution network. Through our international network of dealers, corporations and KOL partners, we will accelerate your sales growth and increase your profitability.
We are absolute professionals for these topics and have accumulated specialist know-how over many years. With many successful projects we have established ourselves as specialists in the market. Our partner organizations qtec group and MTIGER GmbH - Medtech Innovation Germany - are specialized in exactly this field. With the support of our experts and partner companies as a responsible manufacturer of Medical Devices, you as a company do not have to convert your own quality management or adapt it to the applicable provisions of the MDR at great expense.
CE-Med – Ideally from the very beginning
Upon request, our teams accompany the entire lifecycle of a Medical Device, from the creation of Technical Documentation and the analysis of new legal requirements to communication with notified bodies and authorities. Our RA experts are the point of contact for the interpretation, implementation and execution of requirements for Medical Devices and their documentation. Not only do they know their way around, they are also always "up to date" and in a position to make strategically sensible decisions for market access opportunities.
We are the professionals for these topics
We have years of experience and expertise. Our partner organizations qtec Group and MTIGER GmbH - Medtech Innovation Germany - specialize in precisely this area. You can profit from this.
We are happy to develop solutions tailored to your situation and wishes. Let’s talk.
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