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41medical develops medical devices on behalf of clients, from the initial idea to regulatory approval. All regulatory requirements are taken into account to enable a rapid and efficient certification in the respective area.
Our streamlined and proven product development process is offered in flexible packages that can be individually selected according to your need.
We evaluate the project and the potential execution of an idea for a medical problem. The focus is on answering initial questions about feasibility and potential success. After developing the first prototypes and corresponding cost calculations, a business case is created to serve as the basis for decision-making.
New prototypes are developed in quick succession to test the specifications of the future product before the project begins. The development project will only commence once a majority of the specifications have been verified in this phase.
Based on the in-depth feasibility study conducted beforehand, this phase and the next ones focus on the technical development of the medical device, specifically defining user needs and requirements.
If a clinical trial is necessary for the medical device, the required validations and verifications, including all necessary documentation, are prepared, reviewed, and finalized.
The design output takes the requirements defined in the design input and translates them into specifications. This includes production specifications, packaging definitions, labeling, etc., up to the design freeze.
During the design transfer, the initial series production, including the verification of the defined manufacturing process, is carried out. This also includes involving suppliers through contracts and reviewing their documentation.
This phase is characterized by the rigorous testing of the initial series. In addition to the technical aspects of the product, other aspects such as biocompatibility and usability are also examined. These tests are conducted on a risk-based approach to ensure the safety and performance of the medical device.
Preparing documents for future market surveillance and finalizing the technical documentation. Whenever possible, we use our modular TD system, which enables efficient technical documentation and minimizes the effort and costs associated with adjustments.
Communication with country-specific regulatory authorities and, if necessary, implementing the proposed improvements to obtain market approval.
Market launch through sales and partnerships with clinics, as well as data collection to meet regulatory requirements.
As a legal manufacturer of medical devices, we are knowledgeable about regulatory changes, regularly update our processes with the latest insights, and thus enable safe and efficient market introduction.
We provide a cross-functional team consisting of developers, production engineers, quality and regulatory experts, who take care of the respective development project and work closely together. The 41medical expertise is complemented by that of our clinical partners.
Supporting the entire potential of 41medical’s interdisciplinary teams in all phases of development to achieve the common goal with utmost efficiency and quality.
Silas Zurschmiede, Head of Development
We develop and produce solutions for the human musculoskeletal system.
As part of a global network, we have access to researchers, developers and physicians. Our clients include small and medium sized enterprises, start-ups, clinicians as well as international MedTech companies from Europe, USA and Asia.
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