Elena Trombettoni2023-03-29T15:52:58+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: 510K, eSubmission, FDA|
On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days. The Guidance introduces the electronic Submission Template and Resource tool eSTAR, which [...]
adminMTE_04792023-04-21T09:14:17+00:00March 15th, 2021|Categories: Clinical Trial, Europe, MDR, Software|
The European Commission Medical Device Coordination Group has issued a Q&A document on custom made devices. The document includes the definition of custom made device, examples of eligible and non-eligible devices and MDR-related procedures. Contact Meditrial to know how we [...]
adminMTE_04792023-04-21T11:21:20+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: AI, Artificial Intelligence, Digital Health, FDA, Machine Learning, Regulatory, SaMD, Software|
The FDA has released an action plan to develop a regulatory framework on artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). The FDA aims to publish the draft guidance this year. As a Digital Research Organization, Meditrial understands [...]
adminMTE_04792023-04-21T13:04:51+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: Clinical Trial, Digital Health, Innovation, MHRA, UK|
UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in clinical [...]
adminMTE_04792020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: Clinical Trial, Digital Health, EMA, Europe, Innovation|
Digital health technologies are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]
adminMTE_04792020-09-03T07:58:54+00:00September 3rd, 2020|Categories: Clinical Trial, Compliance, Regulatory, Software, USA|Tags: Clinical Trial, Digital Health, FDA, Regulatory, USA|
The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing PRO instruments as well as the possibility of including patient-reported [...]
adminMTE_04792020-08-03T09:20:17+00:00August 3rd, 2020|Categories: Clinical Trial, Software, USA|
The FDA has recently published the user fee amounts which will be collected from medical device manufacturers in fiscal year 2021. Meditrial is the partner for medical device manufacturers in the US. Reach out to Meditrial for clinical or regulatory [...]
adminMTE_04792020-07-29T10:55:55+00:00July 29th, 2020|Categories: Clinical Trial, Software, USA|Tags: FDA, USA|
The FDA finalized a guidance for sponsors regarding the FDA´s review of medical products that contain both medical and non-medical functions. Meditrial has extensive experience with assisting sponsors in regard of FDA requirements for medical devices and software as a [...]
k.janecek2020-06-17T13:20:16+00:00June 17th, 2020|Categories: Clinical Trial, Compliance, Innovation, Regulatory, Software, Switzerland|Tags: Europe, Expert, Innovation, Regulatory, Switzerland, Venturelab|
Dr. Monica Tocchi, CMO and Founder of Meditrial joined the Innosuisse Start-up Training program designed by Venturelab, as a member of their Expert panel. The panel is composed of successful founders, leading academic and industry partners that bring the best [...]
adminMTE_04792020-05-14T08:09:40+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Software|Tags: Covid-19, Digital Health, Europe, European Commission|
The European Commission (EC) shared a Q&A on safe and efficient use of mobile tracing apps across the EU. What is a contact tracing and warning app? A contact tracing and warning app is voluntarily installed and used to warn [...]
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