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 leader of QiA Consulting Group, and the main technical guarantee behind every project the firm undertakes. Her experience is the key factor that allows companies to advance securely in highly regulated environments.
She is an Electronic Engineer, holds a Master's in Biomedical Engineering, and is an ISO auditor, with extensive experience in sanitary regulation, management systems, and regulatory compliance for companies in the health, medical devices, and technology sectors. She has guided organizations in the implementation of ISO 9001, ISO 13485, ISO 27001, as well as in processes before INVIMA, sanitary conditions and CCAA certifications, preparation for inspections, and sanitary registration procedures.
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.
Design, implementation, and intelligent maintenance with AI tools.
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.
