Our Certifications

COVID-19

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. 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.

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.

Regulations

EU MDR

B Medical Systems is certified according to the new Medical Device Regulation (EU) 2017/745, 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.

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.

 

Certifications

SCoPE – AABB’s Standards-Compliant Product Evaluation

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

PQS – WHO’s Performance, Quality and Safety

All B Medical Systems Vaccine Cold Chain solutions are WHO PQS-approved. The PQS qualification confirms that the devices have passed a set of performance, quality and safety tests set by the World Health Organization. Exception applies to RCW2.

CCEOP – Gavi’s Cold Chain Equipment Optimization Platform

B Medical Systems TCW 15 SDD, TCW 15R SDD, TCW 40 SDD, TCW 40R SDD, TFW 40 SDD, TCW 2043 SDD, TCW 3043 SDD, TCW 4000 SDD, Ultra 16 SDD, TCW 40R AC, TCW 80 AC, TCW 2000 AC, TFW 3000 AC, and TCW 4000 AC are listed on the Cold Chain Equipment Optimization Platform established by Gavi, the Vaccine Alliance. The CCEOP eligibility certifies that the devices satisfy the WHO PQS but also present advanced technological features and high level of performance.

ISO 13485

Quality management system for the design and manufacture of medical devices (certificate)

ISO 9001

Quality management system (certificate)

ISO 14001

Environmental management system (certificate)