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B Medical Systems

B Medical Systems S.à r.l. is a Luxembourg-based medical device manufacturing company that has been a pioneer and leading force in the development of cutting-edge solutions for the safe storage and transport of temperature-sensitive life sciences and medical materials including drugs, medicines, biological samples, blood supplies and vaccines.

The company’s core mission is to save lives through reliable and innovative technology, to which end it listens closely to its customers to constantly enhance performance of its products and design high-quality solutions that meet exact user needs.

Over four decades, B Medical Systems has established a reputation as a flexible, reliable and customer-oriented company, recognized for the excellence and performance of its products. Its technology is used in more than 130 countries worldwide, where trained local partners assist users at each step; from selection of right device, to delivery, installation and maintenance.

Product areas

B Medical Systems has developed three principal product families:

Medical Refrigeration

This family comprises state-of-the-art medical devices designed for the safe storage and transport of biomedical materials used in the pharmaceutical and life sciences industries, including academic and research institutes, biobanks and clinical laboratories.

The extensive medical refrigeration family covers storage and transport solutions across the complete cold chain spectrum from -86°C to +15°C, including laboratory, pharmacy and explosion-proof refrigerators, along with laboratory and ultra-low temperature freezers, as well as cold boxes.

The innovative B Medical Systems refrigeration technology allows its refrigerators and freezers to be highly efficient, low-noise and environmentally friendly. B Medical Systems has, for instance, succeeded in reducing ULT Freezer energy consumption by up to 30% and CO2 emissions by more than 5.5 tonnes over a 10-year lifespan, through a combination of frost reduction, adoption of natural gas refrigerants, use of dual inner and outer doors, superior insulation and sealing gaskets. All the medical refrigeration solutions can be equipped with cloud-based temperature monitoring system, which includes documentation functions to comply with US FDA 21 CFR Part 11 guidelines.

B Medical Systems refrigeration solutions are EU MDR and US FDA Class I /II(a) certified.

Blood management

B Medical Systems is respected worldwide for its expertise in providing complete solutions for the safe transport, cooling and storage of temperature-sensitive whole blood and blood components, such as plasma.

These solutions include blood bank refrigerators, plasma storage freezers, ultra-low temperature freezers and transport systems for last mile delivery.

The family also includes contact shock freezers, incorporating patented technology that enables fast and homogeneous freezing of plasma to preserve its essential qualities.

The Blood Management family covers the whole temperature-controlled spectrum from -22°C to +27°C. These are certified as EU MDR and US FDA Class II(a) medical devices, with blood bank refrigerators, plasma storage freezers, and contact shock freezers additionally being SCoPE accredited by the AABB.

B Medical Systems also offers °B Connected technology to ensure traceability across the whole blood cold chain.

Vaccine Cold Chain

As the pioneer of solutions for the safe storage and transport for vaccines worldwide, B Medical Systems has unrivalled expertise in this area. Over more than 40 years, it has developed innovative technology that allows remote communities to have access to efficient vaccines and has worked in close collaboration with public health agencies, national governments, and multilateral organizations to support vaccination campaigns.

B Medical Systems’ vaccine cold chain solutions include ice-lined refrigerators and freezers for health centers with unreliable electricity, SDD vaccine storage equipment running entirely on solar energy, and robust transport systems for lengthy journeys to the remotest communities on Earth. Its Energy Harvesting System allows excess solar power to be used to secure basic needs such as lighting and ventilation, providing vital assistance in the harshest environments.

Company history and structure

B Medical Systems traces its history back to 1979, when the World Health Organization (WHO) asked Electrolux to provide a solution for the safe storage and transport of vaccines worldwide. This initiative led to founding of Dometic Medical Systems as a division of the Dometic Group specializing in vaccine cold chain shipping and storage solutions.

In 2015, Navis Capital Partners took over 100% of the division from the Dometic Group, re-branding as B Medical Systems and expanding its portfolio to blood management and medical refrigeration. The total workforce now numbers more than 220 under the leadership of CEO Luc Provost. The global network covers all six major continents, including a recently established US-based subsidiary with warehouse in Indianapolis, spearheading major expansion of business in North America.

B Medical Systems has established a global support and distribution network of local partners and consultants who have gained credibility in their own right with regional agencies and national authorities, and who are trained to providing best in class support, training and other services.

Quality, Regulatory and Standards

B Medical Systems S.à r.l. has succeeded in obtaining the new EU MDR certification in May 2020, becoming one of the few early adopters worldwide. The certification classifies B Medical Systems’ range of blood bank refrigerators, plasma storage freezers, ultra-low freezers, and contact shock freezers as medical devices Class IIa, demanding stringent clinical requirements and post-market surveillance.

In late 2019, B Medical Systems also succeeded in obtaining the Standards-Compliant Product Evaluation Program (SCoPE) accreditation from the AABB (American Association of Blood Banks) for its plasma storage freezers, contact shock freezers, and blood bank refrigerators, while its cold chain equipment is certified to World Health Organisation PQS standards.

All B Medical Systems devices are also CE marked as meeting the requirements of applicable EC directives. Click on B Medical Certifications for complete statement on quality standards and certificates.

The company is also quality certified to ISO 9001, 14001 and 13485 Standards and has an internal team specifically focused on quality assurance and quality control (QA/QC).

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