What We Do
We provide specialist consulting and digital resources for medical device companies navigating the complexities of regulatory compliance and quality management.
1
ISO 13485:2016 QMS-Implementation
We guide your organization through the full implementation of ISO 13485:2016 — from gap analysis, training and documentation to internal audits and certification readiness. Whether you're building your QMS from the ground up or upgrading an existing system, we provide structured, practical support every step of the way.
2
QMS Automation on Microsoft 365
Stop managing your QMS on paper or disconnected spreadsheets. We design and deploy fully automated QMS solutions using Microsoft 365 and PowerApps — giving your team real-time visibility, streamlined workflows, and audit-ready records, all within tools you already use.
3
ISO 13485:2016 Awareness Corporate Group Training
This half-day awareness training gives your employees a clear, practical understanding of ISO 13485:2016 — what it requires, how it connects to South African medical device regulations, and how every department from Top Management and Quality, to Regulatory Affairs, Sales, Marketing, and Warehousing & Distribution plays a critical part in a compliant Quality Management System.
1
ISO 13485:2016 QMS-Implementation
We guide your organization through the full implementation of ISO 13485:2016 — from gap analysis, training and documentation to internal audits and certification readiness. Whether you're building your QMS from the ground up or upgrading an existing system, we provide structured, practical support every step of the way.
2
ISO 13485:2016 QMS Automation
Our ISO 13485:2016 QMS Automation solution is designed specifically for South African medical device importers and distributors looking to simplify compliance and prepare for regulatory inspections. Automated workflows for document control, training, CAPA, supplier management, and quality records reduce administrative effort, improve traceability, and help keep your Quality Management System audit-ready.
Every implementation includes software validation to demonstrate that your QMS performs as intended, along with practical staff training to ensure your team can confidently manage the system. The result is a compliant, efficient, and scalable QMS that supports your regulatory obligations while allowing you to focus on growing your business.
3
ISO 13485:2016 Awareness Corporate Group Training
This half-day awareness training gives your employees a clear, practical understanding of ISO 13485:2016 — what it requires, how it connects to South African medical device regulations, and how every department from Top Management and Quality, to Regulatory Affairs, Sales, Marketing, and Warehousing & Distribution plays a critical part in a compliant Quality Management System.