Bayer ISO certification sets new standard for medical innovation

Bayer proudly announces its achievement of the ISO 13485 certification. This a globally recognised standard for quality management in the medical device industry.

ISO 13485:2016 is the global benchmark for quality management within the medical device industry. Organisations like Bayer, which achieve this certification, undergo strict audits to ensure compliance with regulatory requirements. This certification highlights Bayer’s dedication to safety, innovation, and excellence in healthcare within South Africa and beyond.

The milestone was celebrated on 14 October at Bayer’s corporate office in Midrand, Gauteng. The event brought together company executives, key stakeholders and JC Auditors (JCA). JCA is a SANAS-accredited certification body responsible for the rigorous compliance review.

A commitment to excellence

Eric Chauke, Bayer’s authorised representative, emphasised the strategic importance of this achievement: “This ISO 13485 certification positions Bayer as a trusted player in the medical device space, enhancing our ability to expand into global markets while sustaining quality and compliance.”

JC Auditors’ managing director, Oliver Naidoo, lauded Bayer’s efforts. “This certification isn’t just a regulatory requirement — it’s a testament to Bayer’s leadership in innovation, patient safety, and operational excellence.”

The recognition came after months of preparation involving system improvements, employee collaboration, and external audits. This effort ensured Bayer’s quality management systems meet international standards in design controls, risk management, and traceability.

A vision for better healthcare outcomes

“This ISO certification aligns with Bayer’s vision to deliver science-driven innovation and create meaningful healthcare solutions,” said Jorge Levinson, Bayer CEO. “It validates our commitment to improving the lives of patients globally by adhering to the highest standards in quality and safety.”

Eileen Visser, quality assurance manager at Bayer, added: “The journey to certification was challenging but refreshing. This accomplishment builds trust among our stakeholders and supports long-term excellence.”

The ceremony concluded with certificate handovers, commemorative photography and networking sessions between Bayer employees and partners.