We design and maintain management systems and certifications that reduce operational burden and ensure permanent compliance with regulations in Colombia.
“Leading the evolution of regulatory compliance and operational efficiency.”
QiA Consulting Group helps healthcare companies, manufacturers, and importers of medical devices, and medical software developers to comply with INVIMA requirements, and to implement, certify, and sustain management systems under ISO 9001 and ISO 13485 standards. We translate regulations into clear, practical, and auditable processes, reducing regulatory risks, avoiding rework, and allowing organizations to focus on growth without slowing down their operation.
Sady Marcela López is the founder and technical guarantee of QiA Consulting Group. As an Electronic Engineer and ISO auditor, she transforms regulation into a competitive advantage.
With extensive experience in the health and medical device sectors, she has guided leading companies through ISO 9001, ISO 13485, ISO 42001, and CCAA certifications, ensuring regulatory compliance and operational efficiency.
Comprehensive support for medical device importers before INVIMA.
Internal audit and strategic preparation to renew your certification successfully.
Comprehensive compliance for manufacturing biomedical devices and equipment.
Execution of regulatory activities before INVIMA with organized evidence.
Specialists in INVIMA and ISO regulations for medical devices.
Focus on reducing administrative burden through technology.
From initial diagnosis to final audit.
Practical, clear approach oriented towards efficiency.
Write to us and let's talk about your organization's needs.
