DQS offers various services in the field of approval of medical devices and certification of management systems in healthcare.

CE marking

MDR (EU) 2017 / 745

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CE marking: Notes on handling unannounced audits

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Flatten-the-Curve? From 2023, the big wave of MDR certifications will be rolling in for notified bodies

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Change of certifier and/or notified body

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MED unannounced audits

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Richtlinie 93/42/EWG für Medizinprodukte
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DQS Medizinprodukte GmbH, Member of DQS Group

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DQS MED presentation slides

Primary packaging materials for medicinal products

ISO 15378

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Change of certifier and/or notified body

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DQS MED presentation slides

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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CE marking: Notes on handling unannounced audits

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Change of certifier and/or notified body

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MED unannounced audits

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DQS MED presentation slides

ISO 13485

ISO 13485:2016 defines the requirements for a quality management system to demonstrate an organization's ability to provide medical devices and related services that consistently meet the requirements of both customers and applicable regulatory provisions.

MDSAP- Medical Device Single Audit Program

 

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries through a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

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Change of certifier and/or notified body

Blog
Richtlinie 93/42/EWG für Medizinprodukte
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DQS Medizinprodukte GmbH, Member of DQS Group

Blog
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DQS MED presentation slides