regZAmed Solutions empowers South African medical device manufacturers to navigate the complex world of quality management and regulatory compliance. We specialize in supporting your journey towards regulatory compliance and quality management excellence.
Unparalleled client service:
No matter where you are in South Africa, regZAmed Solutions can help you achieve quality management and regulatory compliance for your medical devices.
SAHPRA License Applications:
Simplify the process and ensure compliance for both Manufacturers and Distributors/Importers.
FDA 510k and EU CE Mark Approvals:
Expert guidance and support for international market entry.
ISO 13485 Implementation and Maintenance:
Establish and maintain a robust quality management system that inspires confidence and trust.
Why choose regZAmed?
Deep domain expertise:
Our team boasts extensive experience in medical device regulations, both domestic and international.
Proven track record:
We have a history of successful regulatory submissions and satisfied clients.
Comprehensive service portfolio:
From initial concept to market launch, we handle all your quality and regulatory needs.
Personalized approach:
We tailor our services to your specific device and target market, ensuring optimal results.
Join us on the path to regulatory success!
Contact regZAmed Solutions today and let's discuss how we can help you bring your life-changing medical devices to the world.