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

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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.

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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.

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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.

News

Explore our latest news, articles, and events to stay up to date on the trends driving the world of innovation.

ClarkeModet strengthens its Regulatory Services in Brazil with the appointment of Fernanda Manhães

ClarkeModet has appointed Fernanda Manhães as its new Regulatory Services Director in Brazil, strengthening its ability to support healthcare companies in an environment marked by increasing regulatory demands and ever more critical timelines for market entry and continued presence in the Brazilian market. With more than 15 years of international experience in Regulatory Affairs, Fernanda […]

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