Primary Menu Home Our Services Case Studies Join our team About Contact us 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 Product Development Manufacturing After-Sales Service B 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. I 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. T 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 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. Jari Palander Executive Vice President Global Business Development San Francisco, CA David Stelter Vice President Business Development San Diego, CA Joe Ryan Vice President Business Development Columbus, OH Eric Jolain CEO BIT Group France Hematology Expert Get in touch with our experts About BIT BIT develops, manufactures and services high performance clinical, medical and life science devices for international clients. Founded in 1976, BIT employs 350 people and has a presence in San Diego/CA and Irvine/CA (USA), Frankfurt (Germany), Montpellier (France), Kunshan and Shenzhen (China), and Tokyo (Japan). BIT is privately owned and part of Messer World. Newsletter Subscribe to the bi-annual BIT newsletter * Personal data will be encrypted SUBMIT Direct links Hematology Clinical Chemistry Immunology Molecular Histology and Cytology Point of Care Testing Contact us Press Releases Recruiting – Join our team Follow us on Linkedin email us Legal Notice Terms & Conditions Contact us Copyright © [wpsos_year] BIT Analytical Instruments GmbH