Medical devices



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

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# ISO 13485 # Health care certifications # CE marking # Primary packaging materials for medicinal products # MDSAP- Medical Device Single Audit Program

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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Richtlinie 93/42/EWG für Medizinprodukte

DQS Medizinprodukte GmbH, Member of DQS Group

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Change of certifier and/or notified body

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EN ISO 13485
Quality management systems for medical devices
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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DQS MED presentation slides

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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

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Product
EN ISO 13485
Quality management systems for medical devices
Product
Regulation MDR (EU) 2017/745
CE marking for medical devices
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

CE marking

MDR (EU) 2017 / 745

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header-join-dqs-ein mann spricht mit dem team

DQS MED presentation slides

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Blog
Richtlinie 93/42/EWG für Medizinprodukte

DQS Medizinprodukte GmbH, Member of DQS Group

Read more
Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen

MED unannounced audits

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header-join-dqs-ein mann spricht mit dem team

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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interview-join-dqs-eine geschaeftsfrau macht sich notizen

CE marking: Notes on handling unannounced audits

Read more
Product
Regulation MDR (EU) 2017/745
CE marking for medical devices
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

Primary packaging materials for medicinal products

ISO 15378

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

DQS MED presentation slides

Read more
Blog
header-join-dqs-ein mann spricht mit dem team

Change of certifier and/or notified body

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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

DQS MED presentation slides

Read more
Blog
Richtlinie 93/42/EWG für Medizinprodukte

DQS Medizinprodukte GmbH, Member of DQS Group

Read more
Blog
header-join-dqs-ein mann spricht mit dem team

Change of certifier and/or notified body

Read more
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

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