Files & Publications

On this page several folders are maintained with relevant files regarding medical technology.

Files

Safe Application of Medical Technology in Healthcare Institutions

Files that can be useful to implement medical technology regulations

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Files

Masterclass Safe Application of Medical Technology in Healthcare Institutions (2016 and 2017)

In het najaar van 2016 is een aantal masterclasses georganiseerd via de trainingskalender van de NVZ. De uitgereikte documenten treft u hier.

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Files

Templates Medical Technology

In this dossier all kind of formats can be found

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Files

Safe Medical Technology in ZKN Healthcare Providers

This dossier contains files for the safe application of medical technology in healthcare providers that are member of ZKN.

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Files

MDR and IVDR

This folder contains relevant files with regard to the implementation of the revised European legislation of medical devices.

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Files

Cybersecurity

This folder contains relevant documents with regard to the subject of cybersecurity in medical technology.

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Files

Unique Device Identification (UDI)

This folder contains relevant files with regard to the Unique Device Identification program of FDA and EC.

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Files

Covenant Medical Technology in Military Healthcare Providers

On 18 April 2017 a masterclass was organised regarding medical technology in the chain of military units within the NL Defense organisation. T...

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Files

Food & Law

This folder contains files regarding food legislation.

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Files

Predictive Maintenance

This folders contains background information regarding the project Predictive Maintenance.

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Files

Workshop Convenant Medische Technologie, speciaal voor leveranciers

oktober en november 2017

Naar aanleiding van de aankondiging voor de verdiepingsmodule voor ziekenhuizen zijn er veel aanvragen binnengekom...

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Files

Clinical Perfusion

This folder contains files that are related to the workshop Medical Technology for Clinical Perfusionists.

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Files

Medical Technology Reports

This folder contains reports and overviews of the Global, European and National Medical Technology market.

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Files

Toezicht (Dutch)

This folder contains files on how the Dutch government has organized oversight, supervision and enforcement in health care.

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Files

Artificial Intelligence

This folder contains relevant information in the field of Artificial Intelligence in Medical Devices.
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Files

IVDR (In Vitro Diagnostic Medical Device Regulation)

This folder contains relevant files when implementing the IVD Regulation.
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Files

Maintenance Management of Medical Equipment

This folder contains relevant information with regard to Working Group 7 under ISO TC 210. WG7 intends to establish a standard on maintenance managem...
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Files

Custom Made Medical Devices

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue o...
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Files

Medical Device Regulatory Affairs Update

This folder contains the most recent update of Medical Device Regulatory Affairs issues.
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