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

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

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
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

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
Loading...

ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

Blog
Loading...

ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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

CE marking

MDR (EU) 2017 / 745

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?