Quality Certifications ISO 9001 and ISO 13485
with CE Marking in Compliance with MDR 2017/745

We are pleased to share our commitment to quality and excellence in the medical devices we produce. At BionIT Labs, we consistently invest in our infrastructure and business practices to ensure high standards and compliance with industry regulations. As evidence of our efforts, we hold certifications in two important international standards: ISO 9001 and ISO 13485.

ISO 9001: Commitment to Quality and Continuous Improvement
The ISO 9001 certification attests that our quality management system conforms to the rigorous requirements set by the International Organization for Standardization (ISO). This standard focuses on implementing procedures and processes aimed at continually improving the effectiveness and efficiency of our business operations. At BionIT Labs, we consider quality as a strategic priority and a responsibility shared by every member of our team.

ISO 13485: Quality in Medical Devices
The ISO 13485 certification is designed specifically for companies in the medical sector and demonstrates our dedication to the safety and quality of the medical devices we produce. This standard places particular emphasis on risk management, device traceability, and adherence to strict quality control procedures. We are committed to ensuring that every device leaving our facilities meets the highest standards of safety and reliability, contributing to the well-being and improvement of patients’ lives.

CE Marking in Compliance with MDR 2017/745
Additionally, we are proud that our medical devices bear the CE marking, attesting to compliance with the Medical Device Regulation (MDR) 2017/745. This mark signifies our commitment to meeting the rigorous and updated requirements for safety, performance, and quality established by European regulations.

Our Ongoing Commitment
Obtaining and maintaining these certifications is not only a recognition of past efforts but an ongoing commitment to excellence. We will continue to invest in human resources, technology, and procedures to maintain and exceed the standards required by these certifications.
We believe that the quality of our medical devices is crucial to the success of our business and, most importantly, to the health and safety of the patients using our products.

Thank you for your trust in BionIT Labs

We are ready to serve you with the utmost dedication and quality!
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