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

Blog
CAPA for Medical Devices: Common Mistakes and How to Avoid Them
Loading...

CAPA for Medical Devices: Common Mistakes and How to Avoid Them

Blog
Team Unity Friends Meeting Partnership Concept
Loading...

PSUR for Medical Devices under EU MDR: Preparation and Submission

Blog
What is a quality management manual picture document cloud blog
Loading...

Why a QM Manual is Key for High-Quality Standards

Blog
Classification, Medical Devices, MDR, file,
Loading...

Understanding the Classification of Medical Devices under EU 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

Blog
Loading...

Price list of standard fees for the MDR

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
CAPA for Medical Devices: Common Mistakes and How to Avoid Them
Loading...

CAPA for Medical Devices: Common Mistakes and How to Avoid Them

Blog
Blog - ISO 13485 - Certification Process and Maintenance for ISO 13485
Loading...

Certification Process and Maintenance for ISO 13485

Blog
What is a quality management manual picture document cloud blog
Loading...

Why a QM Manual is Key for High-Quality Standards

Blog
Many trucks and trailers are parked at the base, logistics and production center.
Loading...

Efficient Supplier Management for Medical Devices Manufacturers

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.

MED International Medical Device Regulators Forum (IMDRF): A Comprehensive Overview
Loading...

International Medical Device Regulators Forum (IMDRF)

Blog
CAPA for Medical Devices: Common Mistakes and How to Avoid Them
Loading...

CAPA for Medical Devices: Common Mistakes and How to Avoid Them

Blog
Blog - MDSAP - PMS and MDSAP
Loading...

Post-Market Surveillance and Vigilance: Requirements for MDSAP

Blog
MDSAP Audit Approach Enhancing Supplier Selection in Purchasing
Loading...

MDSAP Audit Approach: Enhancing Supplier Selection in Purchasing

Blog
What is a quality management manual picture document cloud blog
Loading...

Why a QM Manual is Key for High-Quality Standards

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

Change of certifier and/or notified body

Primary packaging materials for medicinal products

ISO 15378

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

Change of certifier and/or notified body