Bayer (Pty) Ltd Achieves Prestigious ISO 13485 Certification, Strengthening Commitment to Quality and Innovation

Bayer (Pty) Ltd has reached a significant milestone with the successful certification of its Quality Management System to ISO 13485:2016 – Medical Devices, underscoring its dedication to the highest standards of quality, safety, and regulatory compliance. This achievement reinforces Bayer’s position as a trusted leader in driving innovation and excellence within the South African healthcare and medical device sectors. The South African Health Products Regulatory Agency (SAHPRA) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical device licence, with effect from 1 April 2025 – which effectively means that companies applying for licences from 1 January 2025 would need to be certified (considering the 90-day period before licence expiry). certification and requirements.

ISO 13485 certification is a globally recognised standard that ensures every stage of a medical device’s life cycle — from research and development to sourcing materials, manufacturing, quality control, and packaging — meets the highest levels of safety and quality. The certification process rigorously evaluates compliance with these standards to guarantee full traceability and oversight across specialised functions, including sterilisation etc (where applicable) and contamination prevention for medical products.

By adhering to ISO 13485 requirements, companies demonstrate their commitment to maintaining product integrity throughout the entire life cycle of the device. This ensures that the final product reaching consumers is not only safe and reliable but also performs exactly as intended — offering patients and healthcare providers complete confidence in its quality and effectiveness.

The certificate handover ceremony took place on 14 October 2025 at Bayer’s plush corporate head office in Midrand, where representatives from JC Auditors (JCA) — the SANAS-accredited certification body responsible for the assessment — joined Bayer’s leadership team to celebrate this remarkable accomplishment.

The event commenced with a warm welcome from Eric Chauke,Bayer’s Authorised Representative, who expressed appreciation for the team’s commitment and perseverance throughout the certification process. He highlighted that the ISO 13485 certification places Bayer in a strong position to explore new market opportunities in a rapidly evolving healthcare landscape, where compliance and quality assurance are critical to sustainable growth.

“This certification opens doors for Bayer to expand into new markets and collaborations, ensuring that our products continue to meet global standards of safety, reliability, and performance,” Chauke said.

Delivering the congratulatory address, Oliver Naidoo, Managing Director of JC Auditors, commended Bayer’s leadership for its steadfast commitment to compliance and quality.

“Bayer’s ISO 13485 certification reflects a deep commitment to patient safety, regulatory assurance, and innovation. Their pursuit of quality is not just about meeting standards—it’s about setting new benchmarks for trust and accountability in the medical device sector,” Naidoo stated.

The highlight of the day was the official certificate handover to Bayer CEO, Jorge Levinson, marking the culmination of months of collaboration, internal alignment, and rigorous system assessment.

In his address, Mr Levinson emphasised that this certification aligns perfectly with Bayer’s enduring focus on innovation and its mission to enhance health outcomes across communities.

“Innovation is at the heart of everything we do at Bayer. The ISO 13485 certification reinforces our ability to deliver advanced health solutions that are safe, effective, and trusted. It’s a proud moment that validates our commitment to continuous improvement and our mission to improve health through science and innovation.”

Herman Potgieter, JC Auditors’ Executive Manager, provided a technical overview of Bayer’s certification journey, noting the company’s strong systems in design controls, risk management, and traceability — key pillars of ISO 13485 compliance and operational excellence.

Representing Bayer’s Quality team, Eileen Visser reflected on the audit process and its benefits:

“The certification journey was both rigorous and rewarding. JC Auditors’ professional and collaborative approach provided valuable insights that further strengthened our quality management system. ISO 13485 brings measurable value to our operations and reinforces confidence among our customers and stakeholders.”

The event concluded with individual certificate handovers to Bayer team members — Eric Chauke (AR), Eileen Visser (CQH), and Flucia Molokwane (RA) — followed by group photographs of the Bayer and JCA teams, and a relaxed session of snacks and networking to celebrate this shared success.

About ISO 13485 Certification

ISO 13485:2016 defines the international standard for a quality management system tailored to the medical device industry. It ensures organisations consistently meet customer and regulatory requirements, encompassing design, development, production, storage, and distribution processes. Certification signals strong governance, risk control, and a commitment to patient safety.

Press Contact:

Tranica Ramsunder

BooST Communications - PR and Marketing

This email address is being protected from spambots. You need JavaScript enabled to view it.

About JC Auditors

JC Auditors (JCA) is a SANAS-accredited and IAF-aligned certification body providing a full suite of ISO and compliance certification services across diverse industries. JCA’s Medical Device Division specialises in ISO 13485 certification, helping manufacturers, importers, and distributors meet international quality and regulatory requirements.

For more information, visit 🌐 www.jcauditors.com