2015 - Argevide

NOR-STA in FDA MDDT pilot program

admin — Wed, 23 Sep 2015 09:28:01 +0000

On September 21st Argevide NOR-STA was accepted for the MDDT (Medical Device Development Tools) pilot program implemented by FDA. Under this program, NOR-STA’s suitability as an assurance case tool supporting the development and evaluation of medical devices will be assessed. The evaluation process will take a few months. A positive qualification will mean that FDA confirms the usefulness of the tool in ensuring and demonstrating safety of medical devices. For more information about the MDDT program please visit the FDA.

Food and Drug Administration (FDA) is a US government agency which regulates about 25% of the consumer market in the US, including food market, dietary supplements, drugs, cosmetics, medical devices, electromagnetic radiation emitting devices and biological materials. In many cases, a positive qualification of the product is a prerequisite for admittance to the US market. FDA qualification is also recognized outside the United States as a benchmark of quality and confirmation of the absence of negative effects on health.

Artykuł NOR-STA in FDA MDDT pilot program pochodzi z serwisu Argevide.

Hospital accreditation standards template maintained by CMJ

admin — Fri, 21 Aug 2015 09:29:41 +0000

We are pleased to announce that a cooperation agreement has been signed between Gdańsk University of Technology (GUT) and National Centre for Quality Assessment in Healthcare (CMJ). Its aim is the further development of effective IT support for the processes of quality management in healthcare.

National Centre for Quality Assessment in Healthcare cooperated with Gdańsk University of Technology during the research project “NOR-STA” (2010-2014). The results included the compliance template representing Accreditation Standards in NOR-STA, and the use of NOR-STA in about 40 hospitals for accreditation processes.

The agreement signed in July allows to continue the cooperation between GUT and CMJ in the area of the use of NOR-STA. It includes further development by CMJ of compliance template for hospital accreditation standards. This template will be available for free for NOR-STA users.

Artykuł Hospital accreditation standards template maintained by CMJ pochodzi z serwisu Argevide.

Argevide NOR-STA 6.5.2 released

admin — Tue, 18 Aug 2015 09:21:07 +0000

On August 17 we released NOR-STA version 6.5.2. The new version brings new generic Excel report. The reporting engine allows you to prepare any lists, diagrams and charts, which are updated on the basis of the assessment results in NOR-STA. The report includes also assessment comments. The user can prepare a standard Excel file and use it as a template in many projects and assessments.

Artykuł Argevide NOR-STA 6.5.2 released pochodzi z serwisu Argevide.