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

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.

Blog
Fotolia_195161042_Subscription_Monthly_XXL
Loading...

How to access the Japanese market with medical devices (for overseas companies)

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

DQS MED presentation slides

Blog
Richtlinie 93/42/EWG für Medizinprodukte
Loading...

DQS Medizinprodukte GmbH, Member of DQS Group

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Blog
Doctor working in a lab testing samples
Loading...

Is ISO 13485 right for your company?

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.

 

Blog
Fotolia_195161042_Subscription_Monthly_XXL
Loading...

How to access the Japanese market with medical devices (for overseas companies)

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Who we are - DQS Medizinprodukte GmbH

Blog
Richtlinie 93/42/EWG für Medizinprodukte
Loading...

DQS Medizinprodukte GmbH, Member of DQS Group

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Blog
Doctor working in a lab testing samples
Loading...

Is ISO 13485 right for your company?

Health care certifications

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Who we are - DQS Medizinprodukte GmbH

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

DQS MED presentation slides

Blog
medizinprodukte-zertifizierungsdokumente
Loading...

What to consider when submitting your technical documentation

Blog
unparteilichkeit-ueber-uns-dqs-richterhammer auf holztisch mit waage und gesetzbuechern im hintergrund
Loading...

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

Blog
Doctor working in a lab testing samples
Loading...

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

Blog
medizinprodukte-zertifizierungsdokumente
Loading...

When is software a medical device under the MDR?

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

MED unannounced audits

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

CE marking: Notes on handling unannounced audits

CE marking

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Who we are - DQS Medizinprodukte GmbH

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

DQS MED presentation slides

Blog
Loading...

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

Blog
Richtlinie 93/42/EWG für Medizinprodukte
Loading...

DQS Medizinprodukte GmbH, Member of DQS Group

Blog
medizinprodukte-zertifizierungsdokumente
Loading...

What to consider when submitting your technical documentation

Blog
unparteilichkeit-ueber-uns-dqs-richterhammer auf holztisch mit waage und gesetzbuechern im hintergrund
Loading...

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

Blog
Doctor working in a lab testing samples
Loading...

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

Blog
medizinprodukte-zertifizierungsdokumente
Loading...

When is software a medical device under the MDR?

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

MED unannounced audits

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Blog
digitalisierung-explore-dqs-ein datendiagramm
Loading...

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

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

CE marking: Notes on handling unannounced audits

Primary packaging materials for medicinal products

ISO 15378

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Who we are - DQS Medizinprodukte GmbH

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

DQS MED presentation slides

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body