Professional ISO 13485 & SAHPRA Compliance Solutions in South Africa
Helping Medical Device & Pharmaceutical Businesses Achieve Full Compliance With Confidence
Trusted Quality Management Experts
PM Quality was founded to help South African pharmaceutical and medical device businesses establish strong, practical and compliant quality management systems. With over 15 years of industry experience, we provide tailored compliance solutions that support business growth while protecting patient safety.
Our services are designed for startups, distributors, manufacturers and healthcare organisations seeking practical guidance through ISO certification and SAHPRA regulatory requirements.
Our Core Services
ISO 13485 Gap Analysis
Comprehensive clause-by-clause assessments to identify compliance gaps and prepare your organisation for certification and regulatory inspections.
ISO 13485 Implementation
Full Quality Management System development, documentation and implementation aligned with SAHPRA expectations.
Internal Audits
Independent ISO 13485, ISO 9001, GMP and GDP internal audits performed by certified lead auditors.
SAHPRA Licence Assistance
Professional support with SAHPRA licence applications, renewals and regulatory documentation.
- IRCA & CQI Certified Lead Auditor
- Over 15 Years Industry Experience
- More Than 40 Certification Audits Completed
- Practical Compliance Solutions
- SAHPRA Regulatory Expertise
- Tailored Support For Startups & Established Companies
- Professional & Independent Auditing Services
WHY CHOOSE US?
Our Industry Partners
Certification Bodies
EQMS Service Providers
Ready To Improve Your Compliance Systems?
Partner with PM Quality for expert medical device and pharmaceutical compliance consulting tailored to your business.