Classification strategy
We analyze intended use, technology, risk, manufacturer, and available evidence to define the compliance path before preparing the dossier.
Core sector · Medical devices
INVIMA regulatory management for medical devices in Colombia.
We support manufacturers, importers, and holders with strategy, dossier preparation, product registration, changes, and lifecycle monitoring for medical devices with INVIMA.
Regulatory BPO. INVIMA Legal Holder. Full lifecycle. Colombia · Andean.
End-to-end scope
Regulatory support for every stage of the lifecycle.
Management is not limited to obtaining an authorization. The value is sustaining portfolio continuity with technical judgment and permanent monitoring.
Technical-regulatory dossier
We coordinate information in Spanish or English with manufacturers and internal teams to structure consistent files for INVIMA.
Legal holder and representation
We support holder models for foreign companies or local portfolios that require stable regulatory administration in Colombia.
Authority request response
We prepare technical defense, clarifications, and support when INVIMA requests additional information during review.
Changes and renewals
We monitor validity periods, legal and technical changes, renewals, and events that may affect product continuity in the market.
Quality and suppliers
We integrate auditing, regulatory diagnosis, and supplier review when the case requires strengthening the quality system behind the registration.
Work path
From product to registration with expert judgment.
Each device requires its own reading. Our process organizes the case before moving forward with INVIMA.
Reading01
Device characterization
We review intended use, technology, accessories, manufacturer, evidence, certificates, and market status.
Path02
Regulatory definition
We establish classification, requirements, documentation gaps, quality dependencies, and submission strategy.
Dossier03
Construction and defense
We structure the technical-regulatory file, coordinate support, and respond to INVIMA requests.
Cycle04
Portfolio continuity
We manage changes, renewals, updates, and alerts to prevent market interruptions.
Portfolio coverage
Experience with devices of different technical complexity.
We work with portfolios that combine consumables, equipment, implants, accessories, and technologies with demanding documentation needs.
Devices and consumables
- Instruments
- Sterile consumables
- Kits and accessories
- Clinical support elements
Equipment and technology
- Electromedical equipment
- Monitoring systems
- Associated software
- Technical accessories
Implants and high risk
- Orthopedic implants
- Invasive devices
- Specialized materials
- Critical technical evidence
Next step
Review your device before starting the INVIMA path.
Let's schedule an initial assessment. We identify risk class, documentation gaps, and the best route for your medical device portfolio.