Integral solutions in regulatory compliance and operational efficiency.
We comprehensively manage all regulatory procedures before INVIMA related to medical devices and biomedical equipment, ensuring agile, precise processes aligned with current regulations.
We accompany organizations from the initial technical review to filing, follow-up, and final approval of each procedure, reducing times, rework, and rejection risks.
Manage procedure
We accompany medical device importing and trading companies in the actual execution of the regulatory activities required by INVIMA.
Many organizations have a technical director responsible for regulatory compliance, but day-to-day operational activities make it difficult to keep the system active and documented.
Our Assisted Technical Management System ensures that regulatory activities are executed periodically and have organized evidence for audits and sanitary inspections.
The service is structured in scalable modules that allow for progressive strengthening of the company's compliance system.
We guarantee that regulatory activities are not only defined, but also actually executed and documented.
Implement Assisted Technical Management
We accompany organizations that seek to import medical devices and equipment throughout the regulatory compliance process required by INVIMA for CCAA certification.
We design and structure the required processes, train the personnel involved, and guide the company at every stage of the audit, ensuring a successful and smooth certification.
We support organizations that are close to their CCAA recertification through a complete internal audit that identifies non-conformities, risks, and improvement opportunities.
We implement necessary corrections, strengthen document management, and prepare the team to face the official visit with security, control, and total clarity.
We accompany organizations in full compliance with the requirements demanded by INVIMA for certification in Sanitary Conditions in manufacturing activities of biomedical devices and equipment.
We manage every stage of the process: regulatory interpretation, document structuring, process adequacy, personnel training, and preparation for the official inspection visit.
More information
We accompany organizations throughout the implementation and certification process of ISO 9001 and ISO 13485 standards, ensuring solid, documented management systems aligned with international requirements.
We design and structure each process, train teams, and prepare the company to successfully pass the certification audit.
Our approach combines methodological clarity, document order, and intelligent tools that facilitate daily system management and ensure traceability.
Get certified with us
