notified body

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notified body

A private institution charged by a competent authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Devices Directive; this process, called Conformity Assessment, has EU-wide validity once completed by the notified body.

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References in periodicals archive ?

Notified body review of the technical documentation for Class IIa devices is more thoroughly delineated--the notified body must review at least one representative sample for each device subcategory.

How will Europe's amended device directives change your approach?

The prime function of a notified body is to conduct product life cycle capability governing the design, manufacturability, and in-service life of electrical/electronic appliances.

United States : Intertek Gains Notified Body Status For Gulf Mark (G Mark) Scheme

Nasdaq: MMSI), a leading manufacturer and marketer of proprietary disposable accessories used primarily in cardiology and radiology procedures, announced today that it has received the CE mark from its notified body to market the Impress(TM) catheter in Europe.

Merit Medical Receives CE Mark for Impress(TM) Catheter

19-91100 (Amz); 20-91100 (Bpmz); 21 91100 (BMZ) Series passenger wagons adaptation of the design and manufacturing processes associated with restructuring conducted by one registered in the European Union Notified Body (Notified Body) of the EC verification procedure.

Project-supervision services other than for construction work

As the market leader in medical regulatory compliance, UL simplifies the compliance process for medical devices by providing services for global regulatory needs: FDA 510(k) third-party reviews, MDD / IVDD Notified Body services, CB certification, JIS, INMETRO, PAL, risk management assessments to ISO 14971, management system registrations for the Canadian market and CE Marking to ISO 13485.

Underwriters Laboratories Inc. Co-Sponsors Medtech Insight's Investment in Innovation (In3) WEST Conference

TUV Rheinland, a global leader in independent inspection services said it has become the first international third-party testing, inspection and certification (TIC) company to achieve Gulf Standardization Organization (GSO) notified body status in Thailand and Japan.

TUV Rheinland wins key Gulf certification

As a medical device firm, you are subject to regulatory audits or inspection by the US FDA and EU notified body if you bring your medical device products into the US and EU countries allowing CE-marked products.

Best Practices to Prepare for and Manage Compliance Audits by EU Notified Body and FDA - By Compliance Global Inc

In order to become a Notified Body in accordance with the new regulations, all organizations will have to re-apply.

Upcoming changes to medical device regulation: many Class IIa, IIb and Class III medical devices may lose this status with new revisions

Therefore, "The recommendation aims at ensuring that the notified body carries out a proper verification of the fulfillment of the legal requirements by the manufacturer.

European regulation in flux: with on upcoming EU parliamentary election, the proposed overhaul to the medical device directive is in limbo

They also state that a member state should only designate a notified body after a "joint assessment" conducted with experts from the Commission and other member states, and emphasise that the evaluation reports should be made available to all EU countries.

MEDICAL DEVICES : NEW MEASURES PROPOSED TO PREVENT ANOTHER BREAST IMPLANT SCANDAL

Echo Therapeutics announces acceptance by Notified Body in Europe for its clinical trial plan for Symphony CGM System

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