Medical Devices Department

Expertise & Knowledge

About the department

What do we do?

A multidisciplinary service that combines the expertise and knowledge of our specialists to provide comprehensive support during the complete lifecycle of the device, ensuring compliance with regulatory and quality requirements applicable to medical devices and in vitro devices.

Technical Support

MD and IVD Classification;
Technical documentation;
General Safety and Performance Requirements (GSPRs);
Clinical Evaluation Report (CER);
Gap Analysis.

Compliance

QMS implementation and audit;
Person Responsible for Regulatory Compliance (PRRC);
Risk management.

Post-Market Surveillance

Post-marketing surveillance system;
Post-marketing surveillance plans and reports;
Post-market Clinical Follow-up (PMCF);
Periodic Safety Update Report (PSUR);
Vigilance;
Supply interruption notification.

CE Marking & Registration

Liaison with Notified Bodies (NB);
MD/IVD & Economic Operators Registration.

What we do in the M&S Department

Clinical

Clinical & Non-Clinical CTD modules;
Clinical Addendum;
Text preparation and revision (SmPC and PIL);
Readability tests and bridging reports;
Similarity reports.

Medical

Preparation and review of promotional and non-promotional materials;
Preparation of abstracts, manuscripts, posters and presentations;
Scientific translations;
Advisory boards and roundtables;
Medical inquiries management.

Toxicology

Toxicological reports;
Environmental Risk Assessment (ERA) reports;
Permitted Daily Exposure (PDE) calculation reports.

M&S Team

Our Medical & Scientific team

Verónica Pinho

Medical & Scientific Officer

Medical Devices Department

Bruna Monteiro

Vigilance Senior Officer

Medical Devices Department

Alexandra Miranda

Regulatory Affairs Manager

Medical Devices Department

Frederico Nunes

Medical Devices Director

Medical Devices Department

Mariana Silva

Quality Assurance Manager

Medical Devices Department

Gonçalo Pascoal

Quality Assurance Junior Officer

Quality Assurance Department

Maryna Danylyuk

Quality Assurance Officer

Quality Assurance Department

Mateus Marques

Auditor GxP

Audits Department

Pedro Rodrigues

Auditor GxP

Audits Department

Mariana Borralho

Quality Assurance Officer

Quality Assurance Department

Mariana Ambrósio

Human Resources Manager

Support

Beatriz Neves

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Cátia Saraiva

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Ana Rita Gomes

Medical & Scientific Junior Officer

Medical & Scientific Department

Tânia Lopes

Compliance Officer

Support

Rita Montanha

Quality Assurance Junior Officer

Quality Assurance Department

Joana Rôlo

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Inês Coelho

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Daniela Madeira

Pharmacovigilance Officer

Pharmacovigilance Department

Ana Pacheco

Compliance Junior Officer

Support

Matilde Rodrigues

Medical & Scientific Junior Officer

Medical & Scientific Department

Margarida Corte-Real

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Maria Rocha

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Carolina Dias

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Beatriz Navega

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Daniela Gomes

Auditor PhV

Audits Department

Ana Nogueira

Quality Assurance Officer

Quality Assurance Department

Sarah Matos

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Céline Gil

Pharmacovigilance Officer

Pharmacovigilance Department

Eduarda Soares

Regulatory Affairs Officer

Regulatory Affairs Department

Ana Catarina Correia

Medical & Scientific Officer

Medical & Scientific Department

Margarida Ribeiro

Regulatory Affairs Officer

Regulatory Affairs Department

Inês Silva

Regulatory Affairs Officer

Regulatory Affairs Department

Diana Mendes

Regulatory Affairs Officer

Regulatory Affairs Department

Bernardo Gameiro

Regulatory Affairs Officer

Regulatory Affairs Department

Francisca Ataíde

Quality Assurance Officer

Quality Assurance Department

Matilde Pina

Auditor GXP

Audits Department

Juliana Salvado

Pharmacovigilance Officer

Pharmacovigilance Department

Tatiana Graça

Administrative Officer

Support

Mariana Oliveira

Pharmacovigilance Officer

Pharmacovigilance Department

Nathália Santana

Quality Assurance Officer

Quality Assurance Department

Gustavo Sousa

Auditor GxP

Audits Department

Verónica Pinho

Medical & Scientific Officer

Medical & Scientific Department

Ana Rita Cordeiro

Pharmacovigilance Officer

Pharmacovigilance Department

Bruno Pedro

Medical Advisor

Pharmacovigilance Department

Helena Marques

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Érica Nunes

Pharmacovigilance Senior Officer

Pharmacovigilance Department

André Luz

Managing Director

Managers

Ricardo Andrade

Auditor PhV

Audits Department

César Gonçalves

Auditor GxP

Audits Department

Gabriel Alves

Auditor GxP

Audits Department

Cristina Serra

Auditor GxP

Audits Department

Lara Santos

Auditor GxP

Audits Department

Gabriel Alves

Quality Assurance Director

Quality Assurance Department

Bruno Pedro

Medical Advisor

Medical & Scientific Department

Andreia Mónico

Medical & Scientific Associate Director

Medical & Scientific Department

Lígia Ferreira

Medical & Scientific Director

Medical & Scientific Department

Daniela Gomes

Pharmacovigilance Associate Director

Pharmacovigilance Department

Ricardo Andrade

EU QPPV

Pharmacovigilance Department

Mariana Rocha

Pharmacovigilance Director

Pharmacovigilance Department

Bárbara Macedo

Regulatory Affairs Manager

Regulatory Affairs Department

Gina Abreu

Regulatory Affairs Officer

Regulatory Affairs Department

Guilherme Monteiro

Regulatory Affairs Officer

Regulatory Affairs Department

Adriana Alves

Regulatory Affairs Officer

Regulatory Affairs Department

Dania Shriki

Regulatory Affairs Officer

Regulatory Affairs Department

Libânia Alves

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Marta Almendra

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Elsa Morgado

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Polina Pastoukhova

Regulatory Affairs Officer

Regulatory Affairs Department

Inês Penedones

Regulatory Affairs Manager

Regulatory Affairs Department

Beatriz Matias

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Alexandra Miranda

Regulatory Affairs Manager

Regulatory Affairs Department

Rita Agrela

Regulatory Affairs Senior Manager

Regulatory Affairs Department

Ana Teresa Martins

Regulatory Affairs Manager

Regulatory Affairs Department

Duarte Jesus

Regulatory Affairs Associate Director

Regulatory Affairs Department

Raquel Miguéis

Regulatory Affairs Associate Director

Regulatory Affairs Department

Mariana Pinto

Business Development Manager

Support

Eva Faria

Compliance Manager

Support

Andreia Ferreira

Medical & Scientific Senior Officer

Medical & Scientific Department

Diana Oliveira

Administrative Senior Manager

Support

Ana Margarida Andrade

Regulatory Affairs Director

Regulatory Affairs Department

Sara Oliveira

Medical & Scientific Manager

Medical & Scientific Department

Ana Rita Félix

Medical & Scientific Manager

Medical & Scientific Department

Margarida Tapadas

Quality Assurance Officer

Quality Assurance Department

Carolina Pinto

Quality Assurance Officer

Quality Assurance Department

José Rolim

Quality Assurance Senior Officer

Quality Assurance Department

Mariana Silva

Quality Assurance Manager

Quality Assurance Department

Inês Melo

Quality Assurance Manager

Quality Assurance Department

Ricardo Andrade

Managing Director

Managers

André Luz

Auditor GxP

Audits Department

César Gonçalves

Managing Director

Managers

José Gomes

Audits Director

Audits Department

Beatriz Viegas

Pharmacovigilance Officer

Pharmacovigilance Department

Carolina Mesquita

Pharmacovigilance Officer

Pharmacovigilance Department

Tânia Salvador

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Bruna Monteiro

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Sara França

Pharmacovigilance Associate Director

Pharmacovigilance Department

Ana Isabel Sousa

Pharmacovigilance Senior Manager

Pharmacovigilance Department

Catarina Calado

Pharmacovigilance Manager

Pharmacovigilance Department

Ana Cristina Silveiro

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Get to know our
Medical & Scientific team

Medical & Scientific

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