Combination products under US FDA regulations and comparison with European regulation

por AKRN Scientific Consulting

The global market for combination products (i.e., drug-eluting stents, transdermal patches, infusion pumps, inhalers) has been unstoppably growing over the last decade.

Leer más

MD or IVD software classification (part II)

por AKRN Scientific Consulting

Under the Medical Device Directive (MDD) and the In Vitro Diagnostic Medical Device Directive (IVDD), medical device software (MDSW) was generally considered to be low risk and, therefore, a low-class...

Leer más

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

por AKRN Scientific Consulting

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...

Leer más

#BHHSERIES- MEDICAL DEVICE WEBINAR 'Medical Device Regulation (#MDR) for medical software: Are you ready?'

por Asphalion

The upcoming application of the Medical Device Regulation (#MDR) on May 26th 2021 may signify your digital solution is subject of qualification as a Medical Device. Software as Medical Device (SaMD) m...

Leer más

Mowoot publishes first international study showing its efficacy for chronic constipation

por CataloniaBio

Mo​woot, a start-up and CataloniaBio & Heal​thTech member, has published its first international clinical trial showing the efficacy and safety of the medical device in treating chronic constipati...

Leer más

MDCG: nueva MDCG 2020-17 con las FAQ sobre auditorias remotas de los ON

por Tecno-med Ingenieros

Publicada la revisión de la guia MDCG 2020-4 «Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions» ...

Leer más

Medical Device Software Industry – Germany, pioneer in Healthcare App insured prescription

por Asphalion

By adopting the Digital Healthcare Act (DVG) (October 5th, 2019), Germany became a pioneer in Healthcare App insured prescription, marking one of the greatest milestones for the Medical Device Softwar...

Leer más

MJN obtains the EC certification for its epilepsy aid solution

por CataloniaBio

MJN Ne​uroserveis, a CataloniaBio & HealthTech member, has obtained the CE mark certification for a non-invasive medical device to help people with epilepsy improve their quality of life, together w...

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