How to conduct a clinical investigation of medical devices in Portugal

by AKRN Scientific Consulting

2 years ago
medical devices, Clinical investigations, health care

Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and appropriate experience, preferably in the proposed research...

Recycled raw materials for innovative food supplements, cosmetics or medical devices

by SiTec PharmaBio

3 years ago
NutraCO2S, Recycled raw materials, Medical Devices, Food Supplements, Cosmetic

NutraCO2S project demonstrates that it is feasible to recover and transform agro-industrial production waste into new natural materials rich in bioactive molecules, which could be safely used in Food ...

Digital transformation of medical devices terminal sterilization by means of ethylene oxide

by Telstar

3 years ago
Digital transformation, medical devices, sterilization, ethylene oxide

A new perspective of the future manufacturing process

360º interview with our Medical Device Manager, Talyta Carteano

by Asphalion

3 years ago
Medical Devices

I am a medical device professional with R&D and regulatory background and over 10 years’ experience in the field of Medical Devices, combining a technical background with a fulfilling career in the ...

List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices

by AKRN Scientific Consulting

3 years ago
Medical Devices, In-Vitro Diagnostic, IVDD

A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is a process by which you demonstrate that the produ...

BREXIT | What’s new for Pharma and Medical Devices

by Asphalion

3 years ago
Medical Devices, pharma industry, Brexit

Providing guidance about Regulatory Affairs and Trade changes in the Pharma and Medical Devices industries

WHITE PAPER | The EU Regulatory Environment of Medical Devices Software Development

by Asphalion

3 years ago
Medical Devices Software, MDSW, medical devices

New Medical Devices Software (MDSW) should be developed in Europe in accordance with the requirements of the new legislative framework given by REGULATION (EU) 2017/745 on medical devices (hereinaf...

Dominique Monferrer – New Medical Devices Director

by Asphalion

3 years ago
in vitro diagnostics, Asphalion, Dominique Monferrer, Medical Devices, technologies

Asphalion’s Board of Directors is pleased to announce the appointment of Dominique Monferrer as new Medical Devices Director.

Asphalion celebrates 15,000 followers on LinkedIn!

by Asphalion

3 years ago
Regulatory Affairs, Asphalion, followers, Linkedin, Medical Devices

Today is an exciting day for Asphalion as we have reached 15,000 followers on LinkedIn!

Updates on the Ongoing guidance development within MDCG Subgroups

by Asphalion

4 years ago
MDCG, guidance, artificial intelligence, antibody tests, medical devices, MDR

Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance document...

Nueva sección de la web de la Comision para la puesta en marcha 1/12/2020 del modulo de registro de actores de EUDAMED

by Tecno-med Ingenieros

4 years ago
Single Registration Number, EUDAMED, medical devices

EUDAMED es 22 de mayo de 2022 la Comisión Europea ha confirmado su interés en hacer disponibles los 6 módulos gradualmente, y ha anunciado la apertura del modulo de registro de actores incluyendo e...

Brexit | New guidance documents from MHRA

by Asphalion

4 years ago
medical devices, documents, MHRA, Brexit, medicines

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.