DQS Medizinprodukte GmbH offers various services in the field of approval of medical devices and certification of management systems in healthcare. With our competence, experience and range of services, we can give you a real competitive edge. The value of and trust in our certificates are essential for us and our customers. We stand by this with our commitment to impartiality and independence in the performance of our certification activities.

CE marking

MDR (EU) 2017 / 745

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Price list of standard fees for the MDR

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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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medizinprodukte-zertifizierungsdokumente
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When is software a medical device under the MDR?

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What to do with so-called "material" medical devices under the MDR?

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Great Britain's exit from the EU and the consequences for the medical device market

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medizinprodukte-zertifizierungsdokumente
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What to consider when submitting your technical documentation

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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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What to do with reusable surgical instruments of class "Ir" under the MDR?

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DQS MED - Numbers, data, facts about us

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DQS MED presentation slides

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Who we are - DQS Medizinprodukte GmbH

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.

 

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Change of certifier and/or notified body

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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 - Numbers, data, facts about us

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Who we are - DQS Medizinprodukte GmbH

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 - Numbers, data, facts about us

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DQS MED presentation slides

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Who we are - DQS Medizinprodukte GmbH

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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header-join-dqs-ein mann spricht mit dem team
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Change of certifier and/or notified body

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
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MED unannounced audits

Blog
medizinprodukte-zertifizierungsdokumente
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When is software a medical device under the MDR?

Blog
din-iso-13485-fuer-welche-kunden-dqs-ein mediziner arbeitet im labor
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What to do with so-called "material" medical devices under the MDR?

Blog
unparteilichkeit-ueber-uns-dqs-richterhammer auf holztisch mit waage und gesetzbuechern im hintergrund
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Great Britain's exit from the EU and the consequences for the medical device market

Blog
medizinprodukte-zertifizierungsdokumente
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What to consider when submitting your technical documentation

Blog
header-join-dqs-ein mann spricht mit dem team
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DQS MED - Numbers, data, facts about us

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DQS MED presentation slides

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Who we are - DQS Medizinprodukte GmbH

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

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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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header-join-dqs-ein mann spricht mit dem team
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DQS MED presentation slides