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June 7, 2023
Computer system validation (CSV) is an essential process in the life science industry to ensure that computer systems used in the manufactur...
March 21, 2023
Does your regulatory strategy indicate that the most appropriate regulatory path to market your device in the US is 510(k)?Did you ask yours...
March 8, 2023
In this post we would like to highlight the relevance of appropriate computer system classification based on GAMP 5 guidelines.GAMP 5 establ...
Most companies have a risk methodology in place.In this post, we want to remind you of the critical questions that should guide you during t...
The new In Vitro Diagnostic Regulation (IVDR) 2017/746 is a set of regulations issued by the European Union (EU) for the control and supervi...
When discussing upgrading the company’s quality system and technical documentation to meet the EU-MDR requirements, many of the companies ...
February 12, 2023
A traditional clinical trial is carried out at an investigational site, with all patients traveling to and from sites for receiving the inve...
January 16, 2023
Contract research organizations (CROs) can be excellent assets for companies in the biotech, pharmaceutical, or medical device industries. B...
December 28, 2022
Learn what is A clinical trial protocol, why it’s important, what the protocol should include, and how to conduct a clinical trial with a ...
December 12, 2022
In this article, we will discuss clinical trial monitoring in great detail, including what it is, what processes are involved, and why it is...
November 27, 2022
Just like any project, a clinical trial requires stringent management and control of everything from budgets to timelines and collaborators....
November 8, 2022
Learn what are Clinical trial services and why they are important, and explore the different types of clinical trial services Th...
October 31, 2022
Do you work with software that manages important or even crucial processes in your organization? Are you sure that the results these...
September 12, 2022
Creating a medical device requires you to concentrate on the process of documenting and prototyping phases. In highly regulated areas such a...
May 24, 2022
Gsap is excited to invite you to the MDI Expo 2022 venue: Where the whole Israeli medical devices community meets! MDI Expo 2022 s...
May 8, 2022
Targeted cancer therapy continues to evolve, and many new treatment combinations are being approved in addition to developmental advancement...
May 19, 2022
In the last decade, the cell therapy field has matured, with some notable successes, including CAR-T therapies and gene-modified cell therap...
April 5, 2022
As many of you know, the European Union is going through a significant change in the regulation of medical devices. First was the MDD to MDR...
February 16, 2022
During the past two years, we all were forced to adapt our quality activities, especially, when traveling became difficult and face-to-face ...
February 8, 2022
The continually-evolving field of medical cannabis in Israel poses challenges on medical cannabis companies and start-ups both due to regula...
December 30, 2021
Join us for a minute to explore our journey and main milestones in 2021! Gsap group Gsap, SE Pharma, Almond QMS, Gstudy...
November 14, 2021
For more information about our services visit: Medical Device industry page...
October 21, 2021
Gsap is excited to invite you to the MDI Expo 2021 venue-Where the whole Israeli medical devices community meets! MDI Expo 2021 MDI Ex...
October 6, 2021
So, you want to validate your production processes. This is a great start! There are several benefits to it as shown in this article, but...
September 14, 2021
We are pleased to attend together with SE Pharma for the upcoming IPL Forum 2021- supply chain management conferences for the healthcare and...
August 1, 2021
Gsap provides guidance to the Israeli Medical Cannabis industry: start-Up companies as well as mature companies with established factories. ...
June 28, 2021
Over 300 million people are living with at least one of identified rare diseases around the world. Rare diseas...
June 8, 2021
The food industry is constantly evolving and we are exposed to the need for new ingredients and products for food and drink. In order t...
May 19, 2021
What is reality? In the past, the answer to this question for most people was very obvious- it is the reality that we can approach with ...
April 28, 2021
The Covid-19 Pandemic is one of the greatest challenges modern medicine has ever faced. Hospitals and research labs all over the world are t...
April 13, 2021
The United States Food and Drug Administration (FDA), the European Commission, and other regulators have made patient safety a strategic pri...
February 15, 2021
We are happy to share our range of services that we are providing to the digital health community to accelerate and promote startups- from c...
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 did Gsap experts accelerate Healthcare companies during the COVID-19 pandemic? Interview with Our CEO Dr. Sigalit Ariely-Portnoy ...
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-...
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: FDA COVID-19 EUA – in Vitro diagnostics (IVDs) Europe - emergency market access for IVD manufacturers...
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...
March 8, 2022
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 standards in medical cannabis. The EU GMP presents the requirements for facility, equipment, documentation, ...
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 ...
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 ac...
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...
January 28, 2021
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Topics in this article: The GMP requirements for Post-Harvest in EuropeSubmissions of Medical Cannabis Products in EuropeMedical Can...
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