Medical devices
Class I · IIa · IIb · IIIFrom orthopedic implants and electromechanical devices to consumables and software as a medical device. Full management of product registrations and quality assurance.
Focused coverage by design: we go deeper where our experience builds real value. For pharmaceuticals and food, we deliver expert training.
In these three sectors we operate as a regulatory BPO: local holder, lifecycle management, strategy, liaison, and response to authority requests with INVIMA.
From orthopedic implants and electromechanical devices to consumables and software as a medical device. Full management of product registrations and quality assurance.
Mandatory Health Notification under Andean Community regulations. We act as local holder for foreign companies without a subsidiary in Colombia.
Household and industrial cleaning products, household pesticides, personal hygiene absorbents, and related products.
For pharmaceuticals and food we don't manage regulatory affairs. We offer high-level training for internal teams.
Specialized training in current pharmaceutical regulations, GMP, GWP, and pharmacovigilance for the pharmaceutical industry.
Workshops and corporate training in health compliance for the food and beverage industry.
Each sector has its own rules. Schedule a consultation and we'll explain the specific INVIMA route for your products.