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.

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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...

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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...

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#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...

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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...

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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» ...

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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...

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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...

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