BIT offers proven systematic approaches, steadfast reliability, and an unwavering commitment to quality standards and compliance. We optimize time to market, total cost ownership, and provide complete lifecycle support for IVD devices. Collaborating as “ONE BIT” with state-of-the-art R&D and manufacturing excellence centers in Schwalbach (Germany), Montpellier (France), and Kunshan (China) allows us to serve our clients where they need us. All our sites are ISO 13485 certified, and our regulatory standards include GMP, FDA registration, FDA 21 CFR, and CE-IVDR directive. BIT’s established expertise and proven financial resolve as a division of Messer means that our clients can be completely confident in what we deliver.
We have been working with BIT since early 2016 and have just started our third IVD instrument development project. Having the guidance of an experienced team with very little turnover, the uncertainties of automation development become manageable for an application-driven startup company. BIT has also maintained our aggressive time-to-market schedules and design-to-cost constraints. This is of equal importance of BIT having all functions from instrument design to field service under the same roof and management.
Our strategic partnership with BIT began when our company decided to expand from selling strictly consumables to include a fully automated diagnostic instrument. Not only did BIT take point in the design and development of our instrument, but the team successfully transitioned it into a full production project and later made incremental hard and software improvements based on feedback from the market. The senior management team at BIT was and continues to be very flexible, supportive, and pragmatic in their decision-making process as we collaborate with them. Although they are part of a multibillion-dollar conglomerate, they have the flexible thinking of a medium-sized company. Their senior management team, therefore, remains actively involved in key decisions which is critical for us.
BIT and Siemens Healthineers are looking back on a more than 40 Years successful partnership. I experience this cooperation as a true team approach with a forward-leaning attitude and absolute commitment to ‘deliver’ – be it physical or on project goals. Thanks to our joined focus on quality, we have been able to serve our customers extremely well and through this could establish a solid and respected market position in many diagnostic segments.
We are honored to be included in the Top 10 In Vitro Diagnostics Solution Providers 2023 by the renowned MEDTECH OUTLOOK publication. Read the full interview here.
We are pleased to announce that Jan Wilke has decided to take over responsibility as Managing Director of BIT Analytical Instruments GmbH, effective on September 15, 2023.
Developing a new point of care instrument while keeping costs low will never be an unchallenging process for any engineering team. But with the use of an experienced team with cross-departmental collaboration and a manufacturing mindset, the device will be timely developed in the most cost-efficient manner for your clients.
All our documentation and processes are FDA QSR and ISO 13485 compliant and built to help you through FDA (e.g., 510K or PMA), CE-marking, CSA, and JPAL approval.