Raising the Standard: Introducing Mambokazi Isocred

In the medical device industry, quality isn’t just a goal—it’s a responsibility. From design to production, every step impacts patient safety and trust. That’s why compliance with international standards isn’t optional; it’s essential.

At Mambokazi Isocred, we’ve made it our mission to help medical device manufacturers meet and maintain the highest standards of quality, safety, and performance. Established in 2021, our company brings over 4 years of certification expertise to an industry where precision matters most.

Who We Are

We are an independent ISO certification body specialising in medical device compliance. Our work ensures that businesses not only achieve certification but also understand the standards that keep them competitive and trusted in the marketplace.

What We Do

• ISO Certification Audits – Comprehensive, unbiased audits to verify compliance with ISO standards.

• Conformity Assessments – Identifying strengths, addressing gaps, and confirming compliance readiness.

• Ongoing Compliance Support – Helping you maintain certification long after the audit is done.

• Advisory & Training – Offering tailored guidance on standards, regulations, and best practices.

Why We Exist

We believe that compliance is more than a checkbox—it’s the foundation for safer, better products and healthier businesses. Our approach is human, collaborative, and always focused on helping you succeed without losing sight of regulatory requirements.

Whether you’re a start-up manufacturer or an established industry player, Mambokazi Isocred is your partner in navigating the complex world of certification with confidence and clarity.