KEYMKR has set itself the goal of raising compliance engineering, or the design of medical devices in conformity with standards and regulations, to the next level.
We are convinced that consistent use of a development process and parallel creation of technical documentation effectively leads to better products. For these better products, patient benefit, user benefit and economic success go hand in hand.
We are convinced that in the regulated market of medical technology, compliance engineering and the development of circuit diagrams, sketches and codes are equally significant in the development process. If the development is not compliant, there is no product to be sold.
We think of technical documentation beginning with the conclusion. Being able to verify compliance with the fundamental safety and performance requirements is the goal, and this is what we work towards, starting from the first step of the product description. This is the only way to reach the goal within the deadline and within the budget.
Ultimately, we want safe medical devices on the market. This initially involves supporting the development and design of products that are verifiably safe and that have verifiable benefits. But these products can only display their benefits once they have been launched on the market and are as successful as possible there. For this reason, we help our customers to efficiently find their path to the market. Taking the right steps, in the right order and at the right time of development. This is the only way for us to find safe medical devices on the market when we or our loved ones are patients ourselves and relying on the products.
Thomas Bohnen – April 2022