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Medical devices: technical services
Regulatory

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.
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Regulatory strategy

Clear and tailor-made roadmap to market and regulatory compliance.
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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.
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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.
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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.

Brazil’s Regulatory Transformation: Why Global Life Sciences Companies Should Enter the Brazilian Market Now
Brazil, the largest pharmaceutical market in Latin America, has just removed one of the biggest barriers to entry. Since June 29, 2026, pharmaceutical companies no longer need to have their products registered in another country before applying for registration with ANVISA, the Brazilian health regulatory agency. Combined with a strengthened regulatory reliance framework, this unprecedented […]
Legislative news
Clinical Research & GCP for Brazil and Australia (for USA and European market)
Why Brazil and Australia? Unlocking Opportunities for Diverse and Efficient Clinical Development As sponsors increasingly seek more diverse patient populations, faster recruitment, and efficient regulatory pathways, Brazil and Australia have emerged as two highly attractive destinations for clinical research. Both countries offer unique advantages for global clinical development programs. Brazil provides access to a large, […]
9:00 am San Francisco, PST local time; 12:00 pm New York, EST local time; 5:00 pm Lisbon, London local time; 6:00 pm Madrid, Berlin local time
Online events
Clinical Research & GCP for Brazil and Australia (for APAC market)
Why Brazil and Australia? Unlocking Opportunities for Diverse and Efficient Clinical Development As sponsors increasingly seek more diverse patient populations, faster recruitment, and efficient regulatory pathways, Brazil and Australia have emerged as two highly attractive destinations for clinical research. Both countries offer unique advantages for global clinical development programs. Brazil provides access to a large, […]
09:00 hrs Shanghai local time; 10:00 hrs Tokyo local time; 11:00 hrs Sydney local time
Online events
Brazil’s Regulatory Transformation: Why Global Life Sciences Companies Should Enter the Brazilian Market Now
Brazil, the largest pharmaceutical market in Latin America, has just removed one of the biggest barriers to entry. Since June 29, 2026, pharmaceutical companies no longer need to have their products registered in another country before applying for registration with ANVISA, the Brazilian health regulatory agency. Combined with a strengthened regulatory reliance framework, this unprecedented […]
Legislative news
Clinical Research & GCP for Brazil and Australia (for USA and European market)
Why Brazil and Australia? Unlocking Opportunities for Diverse and Efficient Clinical Development As sponsors increasingly seek more diverse patient populations, faster recruitment, and efficient regulatory pathways, Brazil and Australia have emerged as two highly attractive destinations for clinical research. Both countries offer unique advantages for global clinical development programs. Brazil provides access to a large, […]
9:00 am San Francisco, PST local time; 12:00 pm New York, EST local time; 5:00 pm Lisbon, London local time; 6:00 pm Madrid, Berlin local time
Online events
Clinical Research & GCP for Brazil and Australia (for APAC market)
Why Brazil and Australia? Unlocking Opportunities for Diverse and Efficient Clinical Development As sponsors increasingly seek more diverse patient populations, faster recruitment, and efficient regulatory pathways, Brazil and Australia have emerged as two highly attractive destinations for clinical research. Both countries offer unique advantages for global clinical development programs. Brazil provides access to a large, […]
09:00 hrs Shanghai local time; 10:00 hrs Tokyo local time; 11:00 hrs Sydney local time
Online events
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Meet the medical devices team: technical services

Find the right expert to offer you customized solutions.

Clara Pombo
Clara Pombo Group Chief Regulatory Services Officer

ClarkeModet
Fernanda Manhães
Fernanda Manhães Regulatory Services Director

ClarkeModet Brasil
Mª José Reyes
Mª José Reyes Regulatory Services Director

ClarkeModet España
Cruz Naval
Cruz Naval Regulatory Services Director

ClarkeModet España
Ana Cristina García
Ana Cristina García Country Managing Director Paraguay

ClarkeModet Paraguay
Maria Celeste Pinto
Maria Celeste Pinto Country Managing Director Venezuela

ClarkeModet Venezuela
Fabiana Penadés
Fabiana Penadés Country Managing Director Uruguay

ClarkeModet Uruguay
Conchi Torrejón
Conchi Torrejón Senior Regulatory Consultant

ClarkeModet España
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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.

Claudia Marquez IP Senior Consultant

ClarkeModet México
Victor Fachim IP Senior Consultant

ClarkeModet Brasil
Matheus Aguiar IP Senior Consultant

ClarkeModet Brasil
José Ayala IP Senior Consultant

ClarkeModet Chile
Carlos Tapia Country Managing Director Dominicana

ClarkeModet República Dominicana
Pedro Lages IP Senior Consultant

ClarkeModet Portugal
Brian Gissane International IP Senior Consultant

ClarkeModet Portugal
Maite Sales Regulatory Business Development

ClarkeModet
Martín Roca International IP Senior Consultant

ClarkeModet Brasil
Leo Qi International IP Consultant

ClarkeModet España