Equipo de tomografía en sala clínica, representando dispositivos médicos regulados por INVIMA en Colombia

INVIMA regulatory consulting for Medical Devices and IVDs in Colombia

Specialized boutique consulting firm , +1000 successful projects, 0 sanctioning processes and uninterrupted marketing.

Services

Contact

Results that demonstrate

Eight Years of Excellence

0

SANCTIONS

+1000

FORMALITIES

100%

CONTINUITY

100%

SPECIALIZATION

Equipo de desfibrilación, representativo de dispositivos médicos regulados en Colombia

Services

We offer over 120 regulatory services covering all possible needs of any product portfolio. We have a pro-commercial vision , which allows our clients to carry out their business idea within the current regulatory framework.

Our Method

End-to-end consulting with a pro-commercial vision.

Electrocardiogram icon representing initial analysis in INVIMA regulatory processes

1. Analysis

We establish the best regulatory path based on the business challenge.

Document icon with magnifying glass representing INVIMA regulatory verification and review

2. Preparation

We collect , verify , and optimize all regulatory documentation.

Formal presentation icon, symbolizes filing of procedures before INVIMA.

3. Presentation

We submit your application and give visibility to the process to expedite approval.

Regulatory approval icon used to indicate successful INVIMA procedure

4. Approval

We obtained approval for the procedure

Radar icon to represent continuous monitoring of the INVIMA process.

5. Monitoring

We follow up on the process until it is completed after the subsequent checks .

Us

We have been specializing in medical devices for 8 years , implementing a regulatory strategy that has allowed us to obtain more than 1000 permits. successful , with uninterrupted business continuity for more than 30 clients globally

Further

Incubadora neonatal como ejemplo de dispositivos médicos sujetos a regulación INVIMA

Contact us

Carrera 53c #134-70

regulatory@dd9regulatory.com