BYTEC Medizintechnik GmbH
For more than 25 years we have been developing and producing medical devices with special technical or safety requirements: complex systems for surgery, therapy and diagnostics. Our core competence is the efficient contract development and production of technically demanding or high-risk medical devices in the areas of diagnostics, surgery and therapy. And even during series production, we ensure that your product is the best solution for your customers – by continuing to develop it with you, updating the software, providing on-site service worldwide as well as long-term spare parts logistics.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
- Year Founded:
- 1992
- Employees:
- 11-100
Welcome
Your Partner for Medical Devices: BYTEC
Medical progress needs good ideas, your ideas. We can help you turn them into marketable medical devices. We have been doing this for our customers for more than 25 years.
From Your Idea to Market Success
Our core competence is the efficient contract development and production of technically demanding or high-risk medical devices in the areas of diagnostics, surgery and therapy.
We support you as a certified service provider for the CE marking, FDA approval and the fulfillment of the requirements of the EU’s Medical Device Regulation (MDR).
And even during series production, we ensure that your product is the best solution for your customers – by continuing to develop it with you, updating the software, providing on-site service worldwide as well as long-term spare parts logistics.
About Us
Five good reasons you can succeed with BYTEC
1. Experienced
For over 25 years, we have been dealing with the complex matter of sophisticated medical devices. We know the diverse technological and complex regulatory aspects. We use this expertise for you.
2. Diversified
We do not only serve a single niche market, but many different ones. We have gained great experience and know-how with technologies in other applications that we use for new tasks. This way, we generate innovative, better solutions.
3. Owner-managed
As an owner-managed company, we are independent. We follow your interests, do it quickly, flexibly and efficiently. Our ultimate goal is the market success of your medical device.
4. Your partner
We see ourselves as a partner of our customers, not as simple servants. That's why we work for example, in finding a solution with you, in close and open cooperation. Together we consider how your finished product can be further improved or extended.
5. Responsible
Your success is our success. And that over the entire life cycle of your medical device. That is why we feel responsible for the success of your project, not only up to its market launch, but in all its stages.
To serve you best, we work ...
Oriented toward finding solutions
Well focused, we think and work entirely on finding the best solution. Who has the ideas does not matter, only the result does.
Oriented towards users
A best solution must do more than just work. It must bring real added value to the user, facilitate and improve his work. We are only satisfied when the customer is happy.
Responsibly
Our products are relevant to health, and some are critical for life. We are aware of this responsibility. It commits us to the utmost precision and care.
In a team
We are not geniuses, but our team is ingenious. That's why all of us can and should contribute to finding solutions – including the customer. Seeing each other eye-to-eye, together we always find the optimal solution.
Networked
For the best solution, we also use external specialists and specialist companies. In doing so, we access a very large, proven network that grows in experience every year.
Passionately
We do what we do because we love it. Because we are crazy about technology. And since that is the case, we always do it in the best possible way: with excellent training, with full commitment. For the best result.
Honestly
We do not promise you heaven and earth – we'll tell you how it’s possible. Also what it costs. And if it is not feasible, we’ll say that, too. Openly and honestly.
Our Development
Your idea
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.
Development, implementation
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
Planning security
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.
Approval safety
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.
Product perspective
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.
Service perspective
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
System design
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.
Hardware development
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 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.
Our Production
Production transfer
We define the appropriate processes, technologies and materials and prepare the object under development for production. We do this in collaboration with our development and production department to ensure an optimal production process right from the start. Our motto? Manage the equipment early so that corrections later are not necessary.
Pilot series
With pilot or zero series, we check whether that we have succeeded in transferring the idea from development to production – and that the equipment can also be produced according to the manufacturing instructions that have been created. This way, we establish the series maturity of the object under development.
Series Production
Top quality is our top priority. We carry out the production processes, which we already take into account during the development, exclusively according to international standards.
Quality Assurance, Production documentation
Our quality assurance accompanies the goods and products from the receipt of goods to the specified product, ready for delivery. We record the incoming and outgoing inspections in the production documentation – this ensures quality “Made in Germany.”
Delivery
Complete systems, quality-tested, labeled and ready for dispatch: Together with our logistics partners, we fulfill your wishes in terms of delivery dates as well as shipping method and location.
Lifecycle Management
By internally controlling purchasing, resources, storage and monitoring when components are discontinued, we offer our customers optimum delivery capability and the highest delivery reliability – that is what we call perfect supply chain management.
With your Help: Lean Production
Slimmer is less expensive
We produce according to the principles of lean production: lean, agile and clearly designed. This way, deviations become visible and, thus, can be prevented. The bottom line is lower costs – which we pass on to you. So our advantage will be to your advantage.
Together with you
We include everyone in our production planning, including our customers and suppliers. By integrating all external interfaces into the overall process, we are also able to react quickly and flexibly to customer requests. We trust and cooperate openly with our customers – a benefit for us, but for you as well.