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February 15, 2021
We are happy to share our range of services that we are providing to the digital health community in order to accelerate and promote startup...
February 4, 2021
The Digital Health Revolution is happening all around us and it is both exciting and terrifying. As a member of the Medical Device community...
December 15, 2020
How Gsap experts accelerate Healthcare companies during COVID-19 pandemic? Interview with Our CEO Dr. Sigalit Ariely-Portnoy Re...
October 29, 2020
We are pleased to share with you that on October 22, 2020 The US Food and Drug Administration (FDA) approved the first drug to treat COVID-1...
October 11, 2020
The Nobel Prize for Chemistry was awarded this year for the invention of Genetic Scissors: a tool for rewriting the code of life. ...
April 16, 2020
Topics in this Newsletter 1. FDA COVID-19 EUA – in Vitro diagnostics (IVDs) 2. Europe - emergency market access ...
April 15, 2020
Dr. Sigalit Arieli Portnoy, CEO and Founder of Gsap, talks in an exclusive interview about accelerating the development and approval process...
September 2, 2020
What needs to be reviewed? Technical Documentation which must include:●Device description and specification●Information to be supplie...
September 1, 2020
All companies aim to have high quality products and services, it is the rare few that actually achieve this desirable goal. The way to achie...
February 4, 2020
Learn how to implement EU GMP standarts in medical cannabis.The EU GMP presents the requirements for facility, equipment, documentation an...
January 1, 2020
The FDA takes steps to promote faster access to new medical technologies that are safe and effective: Streamlining premarket procedures, mod...
September 1, 2019
Gsap seeks solutions to the challenges of the medical cannabis industry to place Israeli companies at the forefront of the world. A snapshot...
August 12, 2020
Risk Management is the systematic application of policies, procedures and practice in various aspects and processes of a Medical D...
July 19, 2020
The new Medical Device Regulation (MDR) have been approved on May 2017 and the date for its implementation was May 2020, but recently its im...
August 8, 2019
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring medical device develo...
October 1, 2019
Who isn’t talking about the EU MDR and the new challenges ahead? At Gsap we want to do as well as talk. Gsap has led MDR readiness ...
April 1, 2020
As time passes, keeping track of all the changes in the Global Medical Cannabis market is becoming more and more challenging.The current new...
February 6, 2019
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January 28, 2021
In this newsletter we wish to share our knowledge with you:•The extent of required GMP in post-harvest• Submission of Cannabis products ...
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