k.janecek2024-02-29T14:08:24+00:00April 30th, 2020|Categories: Covid-19, Europe, Regulatory, USA|Tags: Covid-19, Europe, Regulatory, USA|
Both the European and the United States regulatory authorities have issued multiple guidances in response to the COVID-19 emergency, in order to ease the burden on the healthcare system and facilitate the production and import of needed devices during [...]
k.janecek2024-02-07T16:09:22+00:00April 28th, 2020|Categories: Covid-19, USA|Tags: Covid-19, FDA, USA|
The FDA developed a fact sheet in collaboration with the Centers for Disease Control and Prevention (CDC) to help answer questions from the food and agriculture sector about what respirators, disposable face masks, such as surgical or medical masks, or [...]
adminMTE_04792024-02-23T16:59:16+00:00April 27th, 2020|Categories: Compliance, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued guidances to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides and non-invasive fetal and maternal monitoring devices during COVID-19 pandemic. Enforcement Policy for [...]
adminMTE_04792024-02-26T11:42:11+00:00April 24th, 2020|Categories: Compliance, Europe, Innovation, Regulatory, Software, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
The International Medical Device Regulators Forum (IMDRF) issued on April 20th four technical documents covering cybersecurity, personalized devices, conformity assessment bodies and terminologies for categorized Adverse Event Reporting (AER). Following, a short overview on the content of the guidelines: [...]
adminMTE_04792024-02-26T10:57:19+00:00April 21st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act. General provisions Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of [...]
adminMTE_04792024-02-07T16:10:56+00:00April 17th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, USA|
The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. [...]
adminMTE_04792024-02-29T16:35:19+00:00March 31st, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, Helpline, USA|
While global markets are being impacted by COVID-19 pandemic, FDA issues various statements regarding measures to tackle the negative impact on industry and people. Following, we provide a summary of FDA recently introduced regulatory policies. March 31 The FDA [...]
adminMTE_04792024-02-07T16:14:45+00:00March 18th, 2020|Categories: Covid-19, USA|Tags: Clinical Trial, Covid-19, Helpline, USA|
As the COVID-19 emergency impacts all healthcare sectors, the FDA issues guidelines to help industry and researchers. Safeguard of patients’ safety is the key concern, but also avoiding the compromised integrity of important studies due to missing data and [...]
adminMTE_04792024-02-29T13:43:37+00:00March 16th, 2020|Categories: Clinical Trial, Covid-19, Innovation|Tags: Clinical Trial, Covid-19, Helpline, USA|
Meditrial, best-in-class CRO for medical devices, launches new office in the heart of Manhattan. The New York city office is a brand new space to bring together people who share a dedication to innovation. Come visit the Training Center [...]
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