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.

Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Auditor Practical Training | South Africa

Mar 11-15 , 2024, 08:00-16:00 - Apr 22-26 , 2024, 08:00-16:00 - Sep 16-20 , 2024, 08:00-16:00 - Dec 02-06 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Implementer Training | South Africa

Mar 04-05 , 2024, 08:00-16:00 - May 27-28 , 2024, 08:00-16:00 - Aug 19-20 , 2024, 08:00-16:00 - Nov 18-19 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Clause by Clause Training | South Africa

May 07-10 , 2024, 08:00-16:00 - Aug 13-16 , 2024, 08:00-16:00 - Oct 14-17 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Awareness Training | South Africa

Apr 08 , 2024, 08:00-16:00 - Aug 12 , 2024, 08:00-16:00 - Oct 07 , 2024, 08:00-16:00
Online or Classroom | English
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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

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EN ISO 13485 - for which customers?

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.

 

Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Auditor Practical Training | South Africa

Mar 11-15 , 2024, 08:00-16:00 - Apr 22-26 , 2024, 08:00-16:00 - Sep 16-20 , 2024, 08:00-16:00 - Dec 02-06 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Implementer Training | South Africa

Mar 04-05 , 2024, 08:00-16:00 - May 27-28 , 2024, 08:00-16:00 - Aug 19-20 , 2024, 08:00-16:00 - Nov 18-19 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Clause by Clause Training | South Africa

May 07-10 , 2024, 08:00-16:00 - Aug 13-16 , 2024, 08:00-16:00 - Oct 14-17 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Awareness Training | South Africa

Apr 08 , 2024, 08:00-16:00 - Aug 12 , 2024, 08:00-16:00 - Oct 07 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO13485:2016 Hybrid Training

On demand
Virtual Instructor Lead (VILT) | English
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The Passport to the Medical World: Unlocking Global Medical Device Markets

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Celebrating a Milestone: Congratulations to SleepNet|BreatheNet - ISO 13485 certification

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ISO 13485 for Medical Device Manufacturers: Ensuring Safety and Quality Throughout the Product Lifecycle

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ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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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

Blog
header-join-dqs-ein mann spricht mit dem team
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Change of certifier and/or notified body

Blog
din-iso-13485-fuer-welche-kunden-dqs-ein mediziner arbeitet im labor
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EN ISO 13485 - for which customers?

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Auditor Practical Training | South Africa

Mar 11-15 , 2024, 08:00-16:00 - Apr 22-26 , 2024, 08:00-16:00 - Sep 16-20 , 2024, 08:00-16:00 - Dec 02-06 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Implementer Training | South Africa

Mar 04-05 , 2024, 08:00-16:00 - May 27-28 , 2024, 08:00-16:00 - Aug 19-20 , 2024, 08:00-16:00 - Nov 18-19 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Clause by Clause Training | South Africa

May 07-10 , 2024, 08:00-16:00 - Aug 13-16 , 2024, 08:00-16:00 - Oct 14-17 , 2024, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Awareness Training | South Africa

Apr 08 , 2024, 08:00-16:00 - Aug 12 , 2024, 08:00-16:00 - Oct 07 , 2024, 08:00-16:00
Online or Classroom | English
Blog
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ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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

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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

Blog
header-join-dqs-ein mann spricht mit dem team
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Change of certifier and/or notified body

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digitalisierung-explore-dqs-ein datendiagramm
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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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header-join-dqs-ein mann spricht mit dem team
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DQS MED presentation slides

Blog
header-join-dqs-ein mann spricht mit dem team
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Change of certifier and/or notified body