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Our Commitment to Building the Best Quality Products for In-Vitro Diagnostics

In today’s highly regulated market, IVD products must comply with stringent quality, security, and performance standards. This guarantees the safety of medical professionals and patients by ensuring reliable, accurate, and safe diagnostic solutions.

At SFRI, expert scientific teams diligently ensure that all products comply with the norms and quality standards defined in our Quality Management Chart, aligned with ISO 13485 and relevant regulatory requirements.

SFRI rigorously complies with local, regional, and international regulations, as well as corporate standards, including ISO 13485 and CE marking. This commitment ensures clients receive not only high-quality products but also reliable, compliant services that meet evolving global requirements while safeguarding the safety of patients and users.

ISO Certifications

SFRI has maintained ISO 13485 certification since 2006 and operates under the latest 2016 standards, reflecting our long-standing commitment to quality and regulatory compliance. Our rigorous quality management system ensures that every process—from design and production to distribution—meets the stringent safety and regulatory requirements specific to medical devices. By adhering to these internationally recognized guidelines, SFRI consistently delivers reliable, compliant, and high-quality medical device solutions.

ISO 13485 ENG

ISO 13485 FR

CE Mark

All SFRI products carry the CE mark, a symbol of compliance with European Directive 98/79/CE. This mark assures that our reagents and instruments meet the highest European standards for health, safety, and environmental protection. By affixing the CE mark, SFRI demonstrates its commitment to delivering products that are not only reliable and safe but also fully compliant with stringent international regulations.

ANSM (French FDA) Regulations and Inspections

In France, all medical devices fall under the oversight of the Agence Nationale de Sécurité du Médicament (ANSM), the country’s equivalent of the FDA. SFRI ensures that every product is registered and approved by the ANSM before entering the market, demonstrating our commitment to strict regulatory compliance, patient safety, and the highest quality standards.

SFRI is regularly inspected by the ANSM, the French authority for medical devices, to ensure all our products meet strict standards for quality, safety, and health. These inspections also verify our compliance with rules on corporate vigilance, traceability, and accountability, reflecting SFRI’s commitment to reliable and responsible operations.

The ANSM also monitors all SFRI medical diagnostic equipment to ensure it meets France’s official performance and safety standards, ensuring safety and reliability in patient care.