Our Certifications

A reflection of our quality and reliability

B Medical Systems is committed to providing reliable medical devices that meet the highest standards of quality and safety.

As a manufacturer of medical refrigeration solutions designed to protect the integrity of life-saving materials such as blood and vaccines, we understand that the quality of our medical devices is of utmost importance for patient care.

While we constantly aim to drive technological innovation in the medical device industry, we never comprise on our quality standards. By successfully becoming an early adopter of the new EU MDR and AABB’ SCoPE, we have reinforced our position as an industry leader that you can rely on.

In an effort to produce the most reliable medical devices, B Medical Systems has entrusted a highly experienced quality team with running the most stringent quality management system. In close collaboration with all departments, they ensure consistent quality and assure that the medical devices we manufacture are safe and effective.

Regulations

EU MDR & MDD

B Medical Systems is certified according to the new Medical Device Regulation (EU) 2017/745 and Medical Device Directive 93/42/EEC, and all its medical devices are therefore labeled with the CE or CE0123 markings, if Class I or Class IIa respectively.

The Blood Management solutions manufactured by B Medical Systems are medical devices Class IIa. According to the new European regulatory framework, this category of medical devices entails demanding clinical requirements and post-market surveillance.

Our Medical Refrigeration and Vaccine Cold Chain solutions are medical devices Class I.

medical device

US FDA

B Medical Systems is compliant with the US Food and Drug Administration 21 CFR Part 820, which outlines the Current Good Manufacturing Practice CGMP regulations for medical devices.

Our Blood Management solutions are medical devices Class II acc. to FDA regulation 21 CFR Part 864.9700. Our Medical Refrigeration and Vaccine Cold Chain solutions are medical devices Class I acc. to FDA regulation 21 CFR part 862.2050.

Our °B Connected remote temperature monitoring solution also complies with the FDA 21 CFR Part 11 regulation on electronic records and signatures.

Certifications

  • ISO 13485 – quality management system for the design and manufacture of medical devices
  • ISO 9001 – quality management system
  • ISO 14001 – environmental management system
  • Quality Policy – quality and environmental policy