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 compromise on our quality standards. By successfully becoming an early adopter of the new EU MDR and AABB’s SCoPE (Standards-Compliant Product Program), 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

B Medical Systems is certified according to the new Medical Device Regulation (EU) 2017/745, and its medical devices are therefore labeled, when applicable, either with the CE (Class I) or CE0123 (Class IIa) markings.

Please refer to our Vaccine Cold Chain, Medical Refrigeration, and Blood Management portfolio pages or brochures for the specific certifications of each product.

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.

Certifications

AABB’s Standards-Compliant Product Evaluation

The SCoPE accreditation certifies that B Medical Systems’ blood bank refrigerators, plasma storage freezers and plasma contact shock freezers meet the standards of the American Association of Blood Banks. 

WHO’s Performance, Quality and Safety

B Medical Systems’ Vaccine Cold Chain portfolio offers WHO PQS prequalified products. The PQS qualification confirms that the devices have passed a set of performance, quality, and safety tests set by the World Health Organization. Please refer to the individual product pages and brochures for the specific certifications of each product.