We Turn Your Idea
Into A Product
Contract Design and Manufacturing
For Diagnostics, Medical and Laboratory Devices
Loyal partner to our customers for over 30 years!
fast. secure. seamless.
Many companies fail not because of their ideas, but because of a lack of resources, complex regulations, or endless interfaces. This is where DITABIS comes into play.
We are your OEM partner for medical technologies, diagnostics, and life sciences. Our engineering team combines mechanics, electronics, software, and regulatory affairs under one roof. This helps you to avoid wasting time, project chaos, and unnecessary risks.
From early feasibility assessment to DIN EN ISO 13485-compliant series production, we are your agile and experianced wing-man and partner with 30 years of experiance.
Our Divisions
Engineering Services
From concept to a production-ready product: we develop mechanics, electronics, firmware, software, UI and everything else under one roof. Prototyping, technical documentation, and regulatory consulting ensure fast, reliable results.
Production
At our site in Pforzheim (between Stuttgart and Karlsruhe in the South-West of Germany), we manufacture products in small and medium sized series with highest precision. Our well-coordinated and highly flexible assembly lines, a global supplier network, and ERP-supported quality assurance guarantee flexibility, reliability, and cost-effective production.
Certification
Safety right from the start: We develop in accordance with ISO 13485, provide support with CE, MDR and FDA approvals, and deliver audit-proof documentation. This ensures that your product reaches the market without delays and in compliance with all regulations.
Life-Cycle Management
We escort your product until market launch and far beyond – with service, maintenance, spare parts supply, and continuous product care. This ensures that your device remains safe, up to date, and successful for the years to come.
Your
Choices
Work with us to decide on housing shape, materials,
colors, operating concepts, and design
according to your requirements.
Your Advantages
Everything from a single source.
From the initial idea to development and certified series production—at DITABIS, all processes take place under one roof. This saves time, reduces interface losses, and ensures maximum efficiency.
Everything in one place.
Our developers know production inside and out. This means you benefit from cost-optimized design, smart supplier selection, and smooth transition into series production – right here in Pforzheim.
Everything at eye level.
We see ourselves not only as a service provider, but also as a co-developer. With short communication channels, dedicated contact persons, and genuine flexibility, we accompany you over the long term – from the first prototype to life-cycle-management.
How does a project work?
We adapt to your needs! DITABIS is a reliable partner for a wide range of customers, all the way up from start-ups and SMEs to large corporations. Over the years, a certain pattern has developed in our projects, which we generally apply in this or a similar form. Below you will find a brief guide to how a project with us might work:
1. Getting To Know Each Other & Quotation Phase
We start with an open exchange:
your idea, your goals, your framework conditions. On this basis, we prepare an initial feasibility assessment and a preliminary cost estimate – clear, comprehensible, and tailored to your situation.
2. Concept Development
We work with you to develop a viable concept. This involves seamlessly combining mechanics, electronics, software, usability, and regulatory requirements. In this way, we lay the foundation for a product that is both technically and economically convincing.
We summarize the tasks and obligations for you in a catalog of requirements. This allows everyone involved to maintain an overview.
3. Development Phase
Our interdisciplinary teams implement your concept step by step – based on the agreed specifications, transparently, and in compliance with ISO 13485. Prototypes, test series, and comprehensive documentation ensure that your device meets the highest quality standards.
To ensure you always have an overview, we work with clear milestones, regular update meetings, and joint approvals.
And because no project can proceed without changes, we respond flexibly:
In close consultation with you, we implement new requirements in a targeted manner without losing sight of time and cost certainty.
4. Pre-Series Production & Certification
Before your product goes into series production, it undergoes a clearly structured pre-series process at our company – practical and with a view to subsequent approval:
A-Prototype
An initial functional prototype that reflects the essential characteristics of the anticipated product. Ideal for testing functions and obtaining initial feedback.
B-Prototype (usually optional)
An optimized further development of the A-Prototype with a higher degree of maturity. Additional functions are added as required. The devices can already be produced in small quantities – individual components such as housings or mechanics are still produced using 3D printing.
C-Prototype
The pre-series device – manufactured from series components. With the C-sample, we carry out verification and validation, complete test bench and laboratory tests, prepare for approval, and make the final refinements before series production begins.
We complete the certification process together with you and ensure that all the necessary documents are ready for the start of series production. DITABIS ensures that all documents are created in the “Technical Documentation” and are available in accordance with certification requirements. Nothing stands in the way of a successful market launch!
5. Series Transition & Production
The transition from development to series production is smooth at DITABIS – because development and production work hand in hand at the same location.
Our developers know the production process inside out. For you, this means that design decisions are made with production in mind right from the start, suppliers and materials are selected optimally, and production costs are significantly reduced.
At our assembly lines in Pforzheim, we manufacture small series (1 – 500 per year) as well as medium-sized series (500 – 4,000 per year) of your product in accordance with ISO 13485 – flexibly, efficiently, and with maximum process reliability. This means your product idea becomes a reality in series production without any friction losses.
Are you thinking big? We also have a solution for large quantities, depending on the device and complexity! Just get in touch with us.
6. Life-Cycle-Management
Our responsibility does not end with series production – we accompany your product throughout its entire life cycle. This ensures that it remains reliable in use, continues to meet regulatory requirements, and can be further developed technically if necessary.
Series support & product maintenance
We monitor ongoing production batches, document changes, and ensure consistently high quality. Regular reviews and feedback from the field are directly incorporated into the optimization process.
Service & repairs
Defective devices are repaired quickly and reliably. Our service team ensures that downtime is reduced to a minimum.
Further development & updates
We actively respond to technological advances and new market requirements. We develop variants, carry out product updates, and thus extend the life cycle of your devices.
Replacement of discontinued components & reverse engineering
When components disappear from the market, we find alternatives in good time or reconstruct critical parts using reverse engineering. This ensures that your product remains available – without compromising on quality, safety, or approval.
This is how we understand life-cycle-management: a holistic, partnership-based approach that goes far beyond series production and keeps your product successful on the market in the long term.
DITABIS – Your Partner in Germany
1. Who We Are
DITABIS was founded in 1996 and can look back on three decades of experience in medical and laboratory technology. This tradition has enabled us to develop strong values: reliability, quality and a spirit of partnership. Today, we combine this consistency with innovative strength and support our customers as an experienced OEM partner from the initial idea to series production.
2. What Sets Us Apart
Our strength lies in the combination of experience and technological progress. Development, production, certification and life cycle management are seamlessly integrated at our company. This creates trust, reduces risks and enables our customers to bring products to market faster and more securely.
3. How We Work
We rely on interdisciplinary teams that combine technical excellence with practical experience. Fixed contact persons, short communication channels and clear values such as reliability and openness characterise our cooperation. This creates a partnership between equals – based on tradition and continuous development.
4. Where We Want To Go
We look ahead: we think in terms of generations and accompany products throughout their entire life cycle. With product maintenance, service and further development, we ensure that our customers remain successful in the future and that innovations can grow on a stable foundation of experience and values.
DITABIS – FAQ
1. Can we come to you with an early idea without a finished concept?
Yes, absolutely! Many of our customers come to us with just an initial idea or rough sketch. In workshops and feasibility analyses, we work with you to develop a viable concept – one that is technically, economically and regulatory sound.
2. Does the entire scope of the project have to be commissioned, from concept to series production?
No, not necessarily. You decide which phases we support you in. Some customers only commission us with development, others with series production of existing devices.
Of course, you benefit most from our one-stop-shop approach: when development, certification and manufacturing are seamlessly integrated, you save on interfaces, costs and valuable time.
3. How are the intellectual property rights for the developed product regulated?
You retain the IP rights. Everything we develop as part of your project belongs to you. This means you retain full control over your product, your intellectual property and your competitive advantages.
On request, we can also assist you with legally compliant documentation and protecting your developments.
4. What payment options does DITABIS offer?
Over the years, we have successfully implemented various billing models. This depends heavily on the customer’s needs and the project in question. The following models have proven particularly successful:
Development: As a rule, we bill monthly on a time and material basis – transparently and linked to concrete development results. This gives you full cost control and flexibility, especially when it comes to adapting to new circumstances in dynamic projects. However, individual models are possible at any time.
Production: We usually work with fixed prices, which create planning security. Alternatively, we offer open-book models with maximum transparency or individual agreements that are tailored precisely to your needs.
5. How does the certification process for my product work?
As a customer, you are essentially the ‘distributor’ or legal manufacturer of your product. We guide you through the entire process, prepare all the necessary technical documentation and ensure that your device meets the regulatory requirements.
If you do not have certification yourself, we can offer a legal manufacturer solution through our partner network. Alternatively, we can also support you in obtaining ISO 13485 certification yourself, enabling you to act independently as a legal manufacturer in the long term.
Even after successful approval, we remain at your side, providing series support, ongoing documentation and compliance with all regulatory obligations throughout the entire product life cycle.
Convinced?
Then let’s get started!
We look forward to getting to know you and your idea! Please contact our sales team:
Klementina Nagy-Kanasz
Sales & Marketing
Tel.: +49 (0) 176 / 1298 6337
E-Mail.: K.Nagy-Kanasz@ditabis.de