adminMTE_04792024-02-29T17:09:11+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA provided an update to the guidance on the conduct of clinical trials during COVID-19 pandemic. The update aims at providing "general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice [...]
adminMTE_04792024-02-29T16:50:47+00:00September 25th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: FDA, Regulatory, USA|
The U.S. Food and Drug Administration (FDA) has issued a guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body. The standard is recognized [...]
adminMTE_04792024-02-29T16:38:59+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 [...]
adminMTE_04792020-08-31T15:11:17+00:00August 31st, 2020|Categories: Europe, MDR, USA|
With the MDR, EUDAMED will act as central repository of information to lay the foundation for collaboration, transparency and interaction of all parties, namely the new European databank for medical devices and in vitro diagnostic devices. EUDAMED will have several [...]
adminMTE_04792024-02-29T16:58:13+00:00August 17th, 2020|Categories: Clinical Trial, Compliance, USA|Tags: FDA, Regulatory, USA|
The FDA issued the first two device-specific guidances drawing performance criteria to support 510(k) clearance via the new pathway. The FDA had previously proposed an alternate safety and performance based pathway for certain well-understood medical devices. The two final [...]
adminMTE_04792024-02-29T17:10:45+00:00August 13th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid COVID-19. Meditrial is there to help! - Reach out to us for any kind of assistance in regard of [...]
adminMTE_04792024-02-29T17:06:35+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 [...]
adminMTE_04792024-02-29T16:48:12+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 [...]
adminMTE_04792024-02-29T16:40:22+00:00July 23rd, 2020|Categories: Clinical Trial, Compliance, USA|Tags: Covid-19, FDA, USA|
The FDA ordered the exemption five types of Class II medical devices from 510(k) requirements. This decision aims at releaving manufacturers of those devices from some regulatory burden. Meditrial has extensive experience on regulatory matters relating to medical device [...]
adminMTE_04792024-02-02T10:42:51+00:00July 21st, 2020|Categories: Innovation, USA|Tags: Biotechnology, Digital Health, Global Health, Innovators, Regulatory|
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 [...]
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