02 — SEGMENT
MedicalDevicesComplete.
Medical devices, equipment and healthcare materials. From classification to registration and certification.
Reach
Solutions for medical devices
Expertise in all risk classes per RDC 751/2022.
Classification
Correct classification per classification rules.
- Classes I, II, III and IV
- Risk analysis
- Special rules
Registration/Filing
Regularization according to risk class.
- Filing (Class I/II)
- Registration (Class III/IV)
- Change notification
INMETRO Certification
Mandatory certification for equipment.
- Safety testing
- Technical reports
- Conformity marking
CBPF
Good Manufacturing Practice Certificate.
- Inspection preparation
- Gap analysis
- Action plan
IVD - Diagnostics
In vitro diagnostic products.
- Rapid tests
- Laboratory reagents
- Analysis equipment
Technovigilance
Post-market surveillance system.
- Complaint notifications
- Safety alerts
- Recall management
How we work
A clear path, from diagnosis to approval.
The same method in every project: understand the product, chart the route and steer the process to a decision — with visibility at every step.
Diagnosis
Deep dive into the product, the operation and the applicable regulatory framework.
Strategy
Route definition: requirements, documentation, deadlines and owners.
Execution
Dossier preparation, filing and dialogue with the regulatory authority.
Approval and maintenance
Follow-through to the decision and post-approval management to keep everything valid.
Services for this segment
Medical device to regularize?
We manage the entire classification, registration and certification process.