Electronic Submission Template for Medical Device 510(k) Submissions

2024-02-02T10:49:34+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: , , |

On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days.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 [...]

US: FDA Releases Artificial Intelligence/Machine Learning Action Plan

2024-02-29T17:06:58+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: , , , , , , , |

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 The FDA aims to publish the draft guidance this year.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 [...]

UK: MHRA supports generating RWE in clinical trials through digital solutions

2024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: , , , , |

UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials.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 [...]

EU: EMA supports digital health technologies in clinical trials

2020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: , , , , |

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 [...]

US: FDA “green lights” the path for ePRO through regulation

2024-02-29T16:38:59+00:00September 3rd, 2020|Categories: Clinical Trial, Compliance, Regulatory, Software, USA|Tags: , , , , |

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 [...]

US: FDA publishes user fee amounts for medical device manufacturers in 2021

2024-02-29T17:06:35+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 [...]

US: FDA issues final guidance on multiple function device products

2024-02-29T16:48:12+00:00July 29th, 2020|Categories: Clinical Trial, Software, USA|Tags: , |

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 [...]

Meditrial CMO – Dr. Monica Tocchi joins the Venturelab Expert panel

2024-02-29T10:16:35+00:00June 17th, 2020|Categories: Clinical Trial, Compliance, Innovation, Regulatory, Software, Switzerland|Tags: , , , , , |

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 [...]

The European Commission answers questions about COVID-19 tracing apps across the EU

2024-02-29T14:36:51+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Software|Tags: , , , |

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 [...]

Go to Top