OUR SERVICES
From a revolutionary idea to your products in the clinics, hospitals and laboratories – we offer an integrated approach for the lifecycle of your diagnostic devices
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BIT’s product development process draws on more than 40 years of manufacturing, sourcing and long term component reliability service statistics. We believe that we can accelerate your product development, expedite the regulatory approval process and reduce the overall project risk.
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It’s not just a language issue. Sourced materials have slightly different characteristics by country and the health authority approval process can be expedited by being a local producer. Having facilities across the globe, we can build a global product in the best factory suited to the task.
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Time is of the essence when servicing is required. Just as our product development and manufacturing processes are fully ISO 13485:2016 certified, so is our after-sales service. So you can always rest assured that you are compliant with regulations.
In an area where a nano drop of fluid can make all the difference, it has always been our pursuit to support global life science leaders to push the edge of innovation a little further every time.
PRODUCT DEVELOPMENT
Where sweat, discipline and a bit of genius come together to innovate
We turn your ideas and processes into reliable, competitive and compliant medical devices.
This means for our clients that they will have a design which is competitive for the market, robust for daily life and in line with global regulations.
We specialize in diagnostics
In-vitro diagnostics is our home turf, hematology is our particular strength.
USA, Europe, Asia
We are present where life science innovation happens and aware of developments and trends.
Constant improvement
Our R&D teams receive continuous training whether it is IEC 62304, risk management or PCB design.
Design for reliability
Our close knowledge of the manufacturing and service process guides our product design thinking.
We speak Regulatory
We prepare the documentation to get your product approved with the FDA and other local regulatory bodies.
Getting it done
You can rely on BIT to constructively address all challenges together with your team until we get the job done.
BIT is product development
Developing high performance clinical, medical and life science devices to clients and markets globally.
CONTRACT MANUFACTURING
Medical High Tech – Made by BIT
All our plants are ISO 13485 certified
Our ISO and FDA compliance runs through our entire value chain.
Factories in the USA, Europe and China
We can build a global product in the best factory suited to the task.
Global BIT production system
We have a Kaizen-based state-of-the-art manufacturing system embedded in a global sourcing organization.
Sell your medical device everywhere
Our global production presence allows us to manufacture in the market where your product is being sold.
Obsolescence Management
We support your sourcing process to avoid re-certification requirements due to components coming to end-of-life.
40 years of experience
Our success is based on long term relationships with the industry leaders.
We have established and daily applied FDA and ISO 13485 processes to manufacture high quality medium to complex IVD and medical devices in Europe, China and the USA.
This means for our clients that their products are fully compliant and can be sold anywhere in the world.
BIT is manufacturing
Manufacturing high performance clinical, medical and life science devices to clients and markets globally.
AFTER-SALES SERVICES
First class service for first class medical diagnostics devices
We know how critical medical diagnostics devices are for health care providers. That’s why we do everything to keep them working without interruption and in the best possible condition.
This means for our clients that they can rely on BIT to support, or fully manage, their after-sales service.
we extend your service capabilities
We can train your OEM technicians, write service manuals and provide 2nd & 3rd level support hotlines.
worldwide Spare part service
FDA and ISO compliant setup of spare parts for OEMs including planning, manufacturing, handling and shipping.
ISO 13485 compliant service processes
High quality service performance by BIT as a result of our rigorously enforced ISO 13485 standards.
Device Longevity
We can provide functionality updates, refurbishment and relocation services for your devices in the market.
Device Change Management
BIT takes care of changing regulations for compliance with new regulations (e.g. RoHS) and long term parts availability.
Depot service as good as it gets
Our fully equipped repair centers ensure highest service quality.
BIT is after-sales
service
service
Providing services for high performance clinical, medical and life science devices to clients and markets globally.
Working on a new medical device?
Let’s discuss how we can help you develop it faster, accelerate the regulatory process and maintain a high margin throughout the product lifecycle.
Dr. Philippe Grandjean
Vice President
Business Development Global
Frankfurt, Germany
Business Development Global
Frankfurt, Germany
Dr. Josée Naegelen
Vice President
Global Business Development
Hematology
Global Business Development
Hematology
David Stelter
Vice President
Business Development
San Diego, CA
Business Development
San Diego, CA