No matter what stage your idea is in, you will find a competent ear at BYTEC. Whether you are a start-up, SME or corporation, research institution, university or doctor, your idea is what counts.
Specification, risk analysis, proof of concept
Together with you, we develop the specification and the risk analysis – the first and most important step in device development. Here, we tie down everything tight and make your idea ready for praxis.
Implementation plan, system architecture
Already at the start we think of the final. For this reason, we also take into account the market and licensing requirements in the implementation plan, including functional safety. In the system architecture we describe which components comprise your medical device and how they interact.
In various steps, we develop the hardware and software of the medical device. Each development phase is completed by a review, in which we review the results.
Verification, validation, approval
The wedding: Hardware, software, mechanics and design become an overall system. We check this design output against the design input and verify it, taking into account documented changes.
We will gladly assist you with the necessary acceptance tests to validate requirements and with the approval of the medical device.
Your Advantages of Using our Development Expertise
Based on our vast experience and technical expertise, we can easily estimate how much effort and how long a project needs to reach completion. So we offer flexible billing models that fit your company and project – from the fixed price quotation with integrated milestones to the hourly billing per month.
The criteria for approval are an essential part of the development. That is why we will tell you before the kickoff where the challenges of your project are – and how we will master them.
The best advertisement is a product that works. That’s why we look beyond your product’s market launch, but we also plan, for example, ease of use, update and upgrade options and ease of service from the outset.
Is the device robust and practicable in all its parts and, thus, less prone to failure? Can wear parts be easily replaced, components easily reached? Can the software be easily updated and expanded? How must the components be designed so that they can be kept in stock as spare parts for a long time? We solve these and other questions in product development – thus ensuring low follow-up costs.
Our development areas
An efficient design integrates all requirements in one product. These include, for example, specific standards and required safety aspects, the requirements of the application as well as manufacturing and service friendliness.
Innovative switching and control technology is the basis for outstanding medical devices. Our services include, among others, circuit design for analog, digital and high-frequency technology, EMC-compliant design and MR-compatible solutions, layout development all the way to highly integrated multilayer circuit boards or test equipment development.
Software for medical devices must be safe in the first place – but also user-friendly. We develop safe embedded software, intuitive GUI software and test software for you. An efficient software design ensures low development costs and long lifecycles.