Rapid Test Devices

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Having values, we offer strictly professional services and through the recognition and reputation of the A CERT, our associated companies and structures and strategic collaborators, we add value to the products, services, institutes and organizations giving them a competitive advantage and making them capable of achieving a dominant position in national and international level.

Stefanos T. Billas
President, A CERT

Rapid Test Devices

Laboratory activities concerning rapid test devices encompass a wide range of tasks, from evaluation and validation to quality control and research and development.

Key activities include assessing sensitivity, specificity, limit of detection, precision, and accuracy of the devices. Quality control measures ensure consistency, proper storage, and timely expiration monitoring. Training and education are crucial for both laboratory personnel and end-users. Data management and reporting involve recording, analyzing, and reporting test results, patient information, and quality control data. Research and development focus on developing new tests, improving existing ones, and conducting clinical trials. Specific laboratory activities include sample preparation, test performance, result interpretation, quality control testing, data entry and analysis, and troubleshooting.

By effectively performing these activities, laboratories contribute to the accurate and reliable use of rapid test devices, ultimately improving patient care and public health outcomes. High performance rapid test enables immediate treatment or isolation measures to minimize transmission. Accessible, easy-to-deploy, large-scale testing helps contain the virus spread.

Certification for a quality management system is no other than an official recognition of its actual implementation and introduces a competitive advantage for a company towards competition.

Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements.
The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization’s processes so that they consistently turn out products that satisfies customers’ expectations.

Safety net & build wealth

You can transform your business to a revenue-producing asset that lets you work as much or as little as you want.

Business planning & strategy

Our clients are often surprised by the possibilities we present to them; by thinking outside the box we present exciting new ventures:

  • Work fewer hours — and make more money
  • Attract and retain quality, high-paying customers
  • Manage your time so you’ll get more done in less time
  • Hone sharp leadership skills to manage your team
  • Cut expenses without sacrificing quality
  • Automate your business, so you can leave for days,

Research beyond the business plan

The requirements for a quality system have been standardized – but many organizations like to consider themselves as unique. So how does ISO 9001:2008 allow the multiformity, on the one hand for a sole trader, and for a multinational manufacturing company with service components, or a public utility, or a government administration on the other hand?
The answer is that ISO 9001:2008 lays down the requirements a quality system must meet, but does not indicate how they should be met in a particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.

  1. The standard requires the organization itself to audit its QMS according to ISO 9001:2008 – in order to verify that it is managing its processes effectively – or, in other words, to check that it is fully in control of its activities.
  2. In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
  3. Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has been proved extremely popular in the market due to the perceived credibility of an independent assessment.
    The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.

ISO 9001:2008 introduces no new requirements. ISO 9001:2008 introduces just clarifications for the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries up to date.
It also introduces changes intended to improve consistency with ISO14001:2004.

As the name “International Organization for Standardization” would have different acronyms in different languages (“IOS” in English, “OIN” in French for Organisation internationale de normalisation), its founders decided to give it also a short, all-purpose name.
They chose “ISO”, derived from the Greek isos, meaning “equal”.
Whatever the country, whatever the language, the short form of the organization’s name is always ISO.

Business plan market

A strong business plan requires going beyond intuition and experience, and supporting your idea with fact-based market research. Investors need to have confidence in your understanding of the market, so don’t let yourself down by skimping on research. We have access to fee-based, subscriber-only resources such as:

  • Don James/Semplice – Article and News Research
  • VoltageBusiness – Company and Industry Research
  • Goovers – Company and Industry Research
  • IRISpace – Article and News Research
  • Lexos-Nexos – Company, Industry, Market Research
  • Plombett – Article and News Research
  • Pronounce – Market Analysis report “Slices”

Competitor research & analysis

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