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Medicompliance
Representantes
CEO:
Mariana Costa (+351 912 440 093) | mariananetoc@medicompliance.eu
Descrição de serviços

Serviços:

Regulamentação/Certificação Dispositivos Médicos / Apoio Inovação Dispositivos Médicos

Casos de estudo de referência:

SWORD Health - Marcação CE e FDA em menos de 12 meses

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Contactos Gerais
+351912440093
Descrição

We are thrilled to introduce MediCompliance, a startup led by Mariana Neto Costa and co-founded by João Veloso (https://www.ua.pt/pt/p/10320820)

Our mission?

To redefine the path to CE Marking of Medical Devices under European Regulations and FDA guidelines.

At the core of our company is a team of seasoned engineers, each boasting over two decades of expertise. Together, we guarantee unparalleled excellence in every endeavor.

Here's what sets us apart:

  • Technical File Elaboration and Compilation: Comprehensive, compliant documentation for smooth regulatory approval.
  • Accredited Laboratories Testing and Certifications: Ensuring the highest standards of product safety and efficacy.
  • Audits Representation and Leadership: Expert guidance through the audit process.
  • ISO 13485 or ISO 9001 Quality Management System Implementation: Upholding rigorous quality standards.
  • Innovation and European Funding Opportunities: Strategic insights and access to funding to propel your ventures forward.

But that's not all! We're also developing a cutting-edge Decision Support System to digitize and streamline the CE Marking process, heralding a new era of efficiency.

Join us on this transformative journey towards regulatory compliance and technological innovation. Together, we'll exceed expectations. 

Setores Alvo
  • Information and communication
  • Computer programming, consultancy and related activities
  • Information service activities
  • Manufacturing
  • Medical devices
Tecnologias
  • Artificial intelligence, intelligent systems, multi agent systems
  • Wearable technologies
  • Mobile Sensor devices
  • Clinical bioinformatics
  • eHealth
  • Medical engineering
  • Medical devices
  • Business and Management


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