Medical devices: technical services
Navigate medical device regulation to accelerate your time to market with safety and compliance. Medical device regulation, including AI, is becoming increasingly stringent to ensure product safety and performance.
What we do for you
MD/MDSW/IVD Classification
We advise you to correctly classify your medical devices (MD, MDSW, IVD), ensuring that they comply with regulatory requirements and facilitating the definition of the appropriate regulatory strategies.
Regulatory strategy
Clear and tailor-made roadmap to market and regulatory compliance.
Quality system
We implement the quality system according to current regulations.
Pre-clinical and clinical consulting
Technical support in development according to local and international regulations.
Clinical evaluation
Elaboration of technical and clinical documentation to achieve commercialization.
CE marking application
Analysis of documentation to verify compliance with prerequisites, preparation of the technical dossier (GAP analysis) and submission to the competent regulatory authority.
Import and export
Global assistance to operate safely and in compliance.
Everything you need, in one place
- Specific project assessment and strategic accompaniment: identification of steps in the process with structured order.
- Comprehensive support service, connecting with other key agents in the development and commercialization process.
- Understanding of international regulatory frameworks that allow acceleration of registrations before previous approvals (Latin America).
- Experience in software and AI medical devices.
Meet the medical devices team: technical services
Find the right expert to offer you customized solutions.
Contact our experts
Innovation starts with a conversation and a question: how can we help you? Contact the right expert for your needs. We are here to help.
