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On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days.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

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]

EU: European Union and Commission launch EU4Health funding program to boost healthcare digitalization and make devices more accessible

2023-03-31T13:23:04+00:00March 30th, 2021|Categories: Europe, Innovation|Tags: , , , |

As COVID-19 keeps surging throughout many of the European countries, the EU and EU Commission launched EU4Health, the €5.1 billion funding program targeting EU countries, health organisations and NGOs. Aim of the program is to strengthen the resilience of post [...]

ISO issues standard revision ISO10993-23:2021: Biological evaluation of medical devices — Part 23: Tests for irritation

2023-04-21T11:02:51+00:00January 25th, 2021|Categories: Compliance, Innovation, Regulatory|Tags: , |

ISO issued a revision of ISO 10993-1: "ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation". The revised standard "specifies the procedure for the assessment of medical devices and their constituent materials with regard to their [...]

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 The FDA aims to publish the draft guidance this year.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

Dr. Tocchi lecture for Weill Cornell Medicine

2024-02-02T10:42:51+00:00July 21st, 2020|Categories: Innovation, USA|Tags: , , , , |

How to build a Regulatory and Clinical Strategy. Meditrial is thrilled to partner with Weill Cornell Medicine to help biotechnology inventors be successful in globalhealth. Dr. Monica Tocchi will hold a lecture on regulatory. Register here https://lnkd.in/eT7WNWu For more information, click [...]

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 [...]

“Win KOLs and work with partners” – virtual training by Dr. Monica Tocchi for VentureLab

2024-02-01T14:12:57+00:00May 27th, 2020|Categories: Europe, Innovation, Switzerland|Tags: , |

On 4th June 2020, Dr. Monica Tocchi, Founder and CMO of Meditrial will hold a virtual training hosted by Venturelab  – a swiss startup training program commissioned by Innosuisse . This intensive course entitled “Win KOLs and work with partners” is [...]

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