Last 15th September, ANVISA (Agência Nacional de Vigilância Sanitária), the Regulatory Authority of the Medical Devices and IVD market in Brazil, [...]
Last 26th October, the Center for Medical Device Evaluation (CMDE) of the di NMPA (National Medical Products Administration) issued the Notice [...]
Last 11th October, the Italian Ministry of Health issued the document “Vigilanza sugli incidenti con i Dispositivi Medici” which provides specifics [...]
In this Whitepaper you will find the answers to some of the most common Deficiencies issued during MDR (EU) 2017/745 [...]
On 22 September, FDA issued the Electronic Submission Template for Medical Device 510(k) Submissions, a document that provides specifications on electronic [...]
On 5 October, FDA published the Medical Device User Fee Amendments (MDUFA), a document containing updates on the registration fees for [...]
Despite MDR coming into force in 2017 and fully enforceable on 26 May 2021, it is still unclear for medical device [...]
The topic of usability was only of interest to the world of software and electronics, but it has rapidly spread to [...]
The Regulatory Affairs Professional in the medical field plays a significant and decisive role throughout the device’s lifecycle. In this [...]
To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a way [...]
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