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.

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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Who we are - DQS Medizinprodukte GmbH

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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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Change of certifier and/or notified body

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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Who we are - DQS Medizinprodukte GmbH

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DQS MED presentation slides

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medizinprodukte-zertifizierungsdokumente
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What to consider when submitting your technical documentation

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

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

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

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MED unannounced audits

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Change of certifier and/or notified body

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CE marking: Notes on handling unannounced audits

CE marking

MDR (EU) 2017 / 745

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Who we are - DQS Medizinprodukte GmbH

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DQS MED presentation slides

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

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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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medizinprodukte-zertifizierungsdokumente
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What to consider when submitting your technical documentation

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

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

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Change of certifier and/or notified body

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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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CE marking: Notes on handling unannounced audits

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Price list of standard fees for the MDR

Primary packaging materials for medicinal products

ISO 15378

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Who we are - DQS Medizinprodukte GmbH

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DQS MED presentation slides

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Change of certifier and/or notified body

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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DQS MED presentation slides

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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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Change of certifier and/or notified body