Gsap - Quality Services

All companies aim to have high quality products and services, it is the rare few that actually achieve this desirable goal. The way to achieve this goal is by asking and answering 3 questions:

• Do we have a culture for quality and how is that we know this?
• Do we have a quality product and how is that we know this?
• How can we develop and maintain an efficient and effective QMS?

This newsletter gives you practical tools for answering these 3 questions and demonstrates how Gsap can help you to establish a culture for quality, manufacture quality products and have a sustainable, efficient and effective quality system.

Risk Management with ISO 14971:2019

Risk Management is the systematic application of policies, procedures and practice in various aspects and processes of a Medical Device in-order to achieve a safe and effective product.
Risk Management allows the manufacturer to understand the controls and design features needed in their Medical Device.

This process ends only at the end of a Medical Device life-cycle, so even after the Medical Device has been placed on the market, continuous monitoring and identification of new hazards is required.

MDR - From Directive to Regulation, Implications and Impact on Clinical Data Collection

The new Medical Device Regulation (MDR) have been approved on May 2017 and the date for its implementation was May 2020, but recently its implementation was postponed due to the Corona pandemic and currently the target date is May 2021. In this Newsletter, I will briefly highlight the changes in the new regulation related to clinical data collection.

Update on Gsap’s regulatory activity in pharma, biologics, cannabis, IVD and combination products

Here, we have assembled recent regulatory news items from pharma, biologics, cannabis and IVDs. Also, we present a few examples of recent projects from our Pharma/Biotech department.

COVID-19 and In vitro Diagnostics

In the days when the world is facing the corona epidemic, great efforts are being made to find medical solutions to diagnose the infection.Regulatory bodies have also joined the effort and issued guidelines that allow expedited approval of appropriate solutions.

This newsletter focuses on medical diagnostic solutions (IVD for COVID-19). The leaflet details the US, Europe and Israel approaches to accelerated approvals on the issue and also brings Gsap's experience and involvement in promoting related projects.
We wish good luck to the medical device industry, labs and startups in their wonderful initiatives.


Grant Proposal writing

It is already clear to all of our clients that 2020 will be a challenging year, with one of the main challenges being fundraising.

One of the services we provide is assistance with writing grant proposals. During the last month, in particular, due to the COVID-19 pandemic, we have helped clients prepare a large number of grant proposals. These proposals cover various segments of the biomed industry, including pharma (small molecules), biotechnology, cell therapy and medical devices (accessories, active devices, IVD and Digital Health).

Some of the grant proposal timelines are extremely tight.
We can support you in preparing and submitting your proposal, as well as prepare for and participate in meetings with the assessor.

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