As a manufacturer of medical devices and pharmaceutical products, you face the daily challenge of meeting all regulatory requirements with limited resources and responding quickly to changing regulations. These complex requirements demand extensive expertise, as well as an efficient and flexible approach in order to be globally competitive.
We advise and support you as a manufacturer in all challenges that arise in product development. With our processes, methods, and tools, we ensure that your products meet all regulatory requirements and that you can still react quickly and flexibly to changes in the market. We advise and support you throughout the entire product life cycle – from development to market monitoring, to continuous improvement of your products.
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OUR SERVICES FOR MANUFACTURERS
Product safety is our top priority. We support you in implementing an effective quality management system for you and your suppliers. Our reliable document management system ensures that all documents are always up-to-date. We identify and control risks thanks to our model-based risk management system.
We support you in the development of your products. You benefit from our expertise in strategic and operational matters. This includes managing large and small projects, optimizing processes and methods, as well as carrying out analyses, development work, testing, and drawing up technical documentation.
Clinical evaluation is an essential step to demonstrate the safety and efficacy of a medical device. We support you in conducting clinical studies to demonstrate the performance of your products. In addition, we handle customer complaints and incidents – and can also provide our infrastructure, including hardware and software, if desired. We store your data exclusively on our own servers in Switzerland.
After market approval, we handle the monitoring of your products and are available to advise you with our expertise. This ensures that the safety and performance of your medical technology and pharmaceutical products are guaranteed at all times.
In-house specialists are invaluable to companies. That is why we offer targeted training in regulatory requirements and quality management. Through our training courses, your employees will develop an understanding of the complex requirements for medical devices and learn how to successfully implement them in their everyday work.
You can keep track of the complex relationships between your organization and your products thanks to the model-based quality management system, risk management system, and compliance solutions provided by our modelling solutions business unit. This enables you to remain agile in order to react quickly to market changes and drive forward further developments.