About Us
Your Trusted Partner in Medical Device Regulatory Compliance
Seamless SAHPRA Licensing | ISO 13485 Certification | Compliance Solutions
Regulatory & Compliance Solutions for Medical Device Establishments
Medical Maestros (Pty) Ltd, based in Randburg, Johannesburg South, specializes in assisting South African companies in navigating the complex regulatory landscape of the medical device industry. Our expert consulting services ensure seamless SAHPRA (South African Health Products Regulatory Authority) application submissions, regulatory compliance, and quality management system implementation.
Our Services Include:
- Medical Device Establishment Licensing – Assisting with compiling and submitting applications to SAHPRA.
- Regulatory Compliance & Queries – Providing expert guidance on medical device regulations.
- License Amendments – Managing modifications to existing medical device establishment licenses.
- ISO 13485:2016 Compliance – Implementing and maintaining Medical Device Quality Management Systems in line with international regulatory standards.
Partner with Medical Maestros for compliance-driven, efficient, and reliable regulatory solutions tailored to your business
Expert Regulatory Guidance for Your Medical Device Compliance
At Medical Maestros (Pty) Ltd, our team of highly skilled professionals, including pharmacists and regulatory experts, is dedicated to ensuring your medical device establishment meets both SAHPRA regulations and international standards like ISO 13485.
✅ End-to-End Regulatory Support
✅ SAHPRA Compliance & Licensing
✅ Expert-Led Quality Assurance
With a commitment to precision and excellence, we go the extra mile to simplify the regulatory process, helping you navigate compliance with confidence.