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

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
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Using MDSAP to Manage Many Regulatory Systems for Medical Devices

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Instructor Led Training

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

Sep 16-20 , 2024, 08:00-16:00
Online or Classroom | English
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Instructor Led Training

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

Aug 19-20 , 2024, 08:00-16:00
Online or Classroom | English
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Instructor Led Training

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

Aug 13-16 , 2024, 08:00-16:00
Online or Classroom | English
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Instructor Led Training

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

Aug 12 , 2024, 08:00-16:00
Online or Classroom | English
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Event

MDSAP Overview Training

Undated
Online | English
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Change of certifier and/or notified body

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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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Unlocking Innovation in Healthcare: The Critical Role of Software as a Medical Device (SaMD)

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Blog
Vector English Revolutionizing Healthcare The Impact of Machine Learning-Enabled Medical Devices now

Revolutionising Healthcare: The Impact of Machine Learning-Enabled Medical Devices now and in the future

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Instructor Led Training

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

Sep 16-20 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

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

Aug 19-20 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

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

Aug 13-16 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

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

Aug 12 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Blog

ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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Blog
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MED unannounced audits

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Change of certifier and/or notified body

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

CE marking: Notes on handling unannounced audits

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Product
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

Primary packaging materials for medicinal products

ISO 15378

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

Change of certifier and/or notified body

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CE marking

MDR (EU) 2017 / 745

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

MED unannounced audits

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

Change of certifier and/or notified body

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

CE marking: Notes on handling unannounced audits

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Blog

Price list of standard fees for the MDR

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

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

Efficient Supplier Management for Medical Devices Manufacturers

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Blog
Depositphotos_298305132_XL 1.jpg

Unlocking Innovation in Healthcare: The Critical Role of Software as a Medical Device (SaMD)

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Unrecognizable doctor sharing health care data with medical staff via networked, secure, mobile devi

Discover the Benefits of ISO 13485 for your Business

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Instructor Led Training

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

Sep 16-20 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

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

Aug 19-20 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

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

Aug 13-16 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

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

Aug 12 , 2024, 08:00-16:00
Online or Classroom | English
Read more
Instructor Led Training

ISO13485:2016 Hybrid Training

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

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Blog
Innovative technology in a modern hospital operating room futuristic medical interface concept Keepi

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

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Blog
Innovative technology in a modern hospital operating room futuristic medical interface concept Keepi

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

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Blog

ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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Blog
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Change of certifier and/or notified body

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Product
Taiwan Technical Cooperation Program (TCP lll)
Approval for medical devices in Taiwan
Product
ISO 13485
Quality management systems for medical devices
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

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