Service

Qarad b.v.b.a.

Cipalstraat 3 , 2440 Geel
Belgium

Telephone +32 14 570544
Fax +32 14 582387
info@qarad.com

This company is co-exhibitor of
Flanders Investment & Trade/ Flanders Care

Trade fair hall

  • Hall 3 / J74
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 3): stand J74

Fairground map

MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.08  Logistic services

Logistic services

  • 07  Medical Services and Publications
  • 07.08  Logistic services
  • 07.08.18  Profitability consulting

Profitability consulting

Our products

Product category: Logistic services, Profitability consulting

CE marking

CE marking
Medical devices or in vitro diagnostics that are placed on the European market, must meet the requirements of their respective European Directives. Conforming products will receive the CE mark or label as the evidence of compliance.

Qarad offers a complete list of services to assist the manufacturer in obtaining the CE mark for his products.

These services for CE marking include:
Full management of the manufacturer’s regulatory affairs. Small or medium sized manufacturers can outsource all their regulatory activities to Qarad’s experts for effective regulatory affairs management.

  • General consulting and training on the medical devices (MD) and in vitro diagnostics (IVD) Directives and their impact on your business and operations.
  • Practical training sessions on specific parts of the Directives, such as risk analysis and the composition of technical documentation. Qarad has developed an efficient system for risk analysis and makes document packages available for the creation of technical documentation and for facilitating conformity assessment.These sessions will help you understanding all requirements for CE Marking.
  • Review of your technical documentation to identify any deviations from the regulatory requirements.
  • Composition of technical documentation and design dossiers for notified body assessment.
  • Review of your Instructions for Use and product labels. Advise in the design of labeling and optimization for translation. Translation of your instructions for use through our network of specialized translators.
  • Audit (gap analysis) of your quality system versus the Directives’ quality system requirements and ISO13485.
  • Assistance in notified body selection and in the preparation for a conformity assessment by the notified body.
  • Advise in the classification of medical devices and borderline products.
  • Organization of performance evaluations for in vitro diagnostic products, including Annex II products and self-testing products.
  • Assistance in the composition of clinical data and the organization of clinical investigations for medical devices.
  • All interactions with the competent authorities.
  • Notification of CE marked products to the national competent authorities.
  • Support in the case of regulatory actions by authorities versus manufacturers or products in the market.
  • Management of incidents: incident notification, recall, editing of advisory notices.

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About us

Company details

QARAD provides manufacturers of in vitro diagnostics and medical devices
with the necessary services to obtain the CE mark, FDA clearance and quality system certification (ISO9001, ISO13485).

QARAD's services include training, consulting, auditing, risk analysis, compiling
of technical documentation and labeling management, including translation and
achieving compliance with directives on dangerous substances and preparations.
It also acts as Authorized Representative.

Qarion E-Labeling Services: a unique fully compliant system for the distribution of instructions-for-use of IVD products through the internet and including multilingual Freephone support in all European countries.

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Company data

Sales volume

< 1 Mio US $

Export content

max. 75%

Number of employees

1-19

Foundation

2000

Area of business
  • Diagnostics
  • Information and Communication Technology
  • Medical Services and Publications