European medical devices standards

Farum SA - History

Before you can sell a medical device or IVD in Europe, place a CE Mark (CE Marking) on ​​your product. The CE Mark is a quality brand and is not intended for consumers. It is a declaration by the manufacturer which legally binds your product has met all the requirements of the Medical Device Directive (MDD 93/42/EEC), the Directive on In Vitro Diagnostic Devices (IVD 98/79/EC) or Directive of Active Implantable Medical Devices (AIMD 90/385/EEC), as appropriate.

Medical Device Directives stipulate that companies must do the following before you can apply the CE Mark to its medical device or IVD:

  • Prepare a Technical File for CE Marking (or design dossier for Class III) with proof of compliance with the Medical Device Directive (or the Directive of In Vitro Diagnostic Devices (IVD) or Active Implantable Medical Devices (AIMD) .
  • Receive a certificate CE Mark of a Notified Body if the device is Class I sterile or with a measuring function, Class IIa, IIb, or III.
  • Appoint a European Authorized Representative if you have no physical location in Europe.
  • Register medical devices with the competent authorities, where appropriate.

Only after meeting these compliance requirements of CE, shall be entitled to place the CE mark on your medical device.

Emergo Group has helped hundreds of medical device companies with CE Mark approvals. Our services include:

  • Technical File for CE Marking and preparation and review of design files.
  • Verification of the essential requirements.
  • Classification and identification of the product according to applicable standards for medical devices.
  • Implementation and maintenance of quality systems based on ISO 13485.
  • Labeling and packaging review.
  • Assessment and Risk Management (ISO 14971).
  • Development Monitoring and service request, and even standard operating procedures and monitoring processes.
  • European Authorized Representative.

Our management systems quality requirements can be met Europeans, Americans, Canadians, Australians and Japanese Pharmaceutical Affairs Law.

Emergo Group can develop a system of quality management through the application certificate of ISO 13485:2003 to ensure that they meet the requirements of quality systems for Europe. Each system is tailored to the manufacturer and can not only ensure compliance with the European Medical Device Directives (CE Mark), but also the Canadian Medical Device Regulations, the requirements of the Classification System of Quality (QRS) clearance of the United States, the Therapeutic Goods Administration (TGA) of Australia, and the Japanese Pharmaceutical Affairs Law.

2011-03-01 13:00:06 by csipodunk

McAfee/Intel

Would this indicate that a virus is capable of invading a processor? Other related links at the bottom of the full cnet article.
March 1, 2011 6:18 AM PST
Intel completes McAfee acquisition
by Lance Whitney
Intel has completed its $7.68 billion acquisition of McAfee.
The completion of the deal, announced yesterday, follows approvals by the various boards of directors and stockholders, as well as reviews by the Federal Trade Commission, the European Commission, and other regulatory groups

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