NAMSA and ÅKRN: Providing full continuum Medtech Develoment Solutions

por AKRN Scientific Consulting

NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its intent to acquire ÅKRN Scientific Consulting, a prominent Euro...

Leer más

Artificial Intelligence challenges in Medical Devices

por AKRN Scientific Consulting

Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used as a medical device or being a medical device by it...

Leer más

Drug or Device? Summary and analysis of MDCG 2022-05 on borderline products

por AKRN Scientific Consulting

This article summarizes the guidance document released by the Medical Device Coordinating Group (MDCG 2022-5) to support manufacturers in qualifying borderline products.

Leer más

Fellow Program: La incubadora de talento de una CRO

por AKRN Scientific Consulting

La demanda de productos sanitarios se encuentra en constante aumento, un nicho de oportunidades donde escasean profesionales y talento para satisfacer las necesidades del sector tecnológico-sanitario...

Leer más

Auditing a QMS according to ISO 13485

por AKRN Scientific Consulting

When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed, medical device manufacturers must first ensure th...

Leer más

Clinical Performance Study applications for IVDs in Spain

por AKRN Scientific Consulting

In vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of the In Vitro Diagnostic Medical Device Regulation (...

Leer más

Safety reporting for clinical investigations under the MDR

por AKRN Scientific Consulting

Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP), stakeholders are required to comply with the Medical D...

Leer más

Performance Studies for SARS-CoV-2 IVD tests

por AKRN Scientific Consulting

Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD tests. These two documents have strengthened the requ...

Leer más

A practical guide to conduct clinical investigations under the MDR

por AKRN Scientific Consulting

The implementation of the Medical Device Regulation (EU) 2017/745 (hereinafter referred to as MDR) has set new requirements for performing clinical investigations. Indeed, whereas the previous directi...

Leer más

How to set up agreements to conduct a clinical investigation?

por AKRN Scientific Consulting

Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020, the EU MDR 2017/745, the EU IVDR 2017/746, the EU...

Leer más

How to conduct a clinical investigation of medical devices in Portugal

por AKRN Scientific Consulting

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

Leer más

Impact of MDCG 2021-21 on SARS-CoV-2 IVDs

por AKRN Scientific Consulting

This article will provide you information on MDCG 2021-21 guidance document and let you know how you can place and keep your SARS-CoV-2 IVD products on the EU market.

Leer más
Subscribirse al Directorio
Escribir un Artículo

Últimas Noticias

El diagnóstico genético neonatal mejor...

Un estudio con datos de los últimos 35 años, ind...

Más de 1.500 cambios epigenéticos en e...

Un equipo de investigadores de la Universidad Juli...

Tuneable reverse photochromes in the sol...

A new technique allows the design of solid materia...

Destacadas

Eosinófilos. ¿Qué significa tener val...

by Labo'Life

En nuestro post hablamos sobre este interesante tipo de célula del si...

Un estudio de INCLIVA muestra el efecto ...

by INCLIVA

Han desarrollado un estudio para evaluar la correlación entre el teji...

Diapositiva de Fotos