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Medical devices certifications



We are a certification and notified body with over 20 years of experience leveraging quality within the medical devices industry—personalised, agile, and global.

Our accredited certifications enable players in the medical device industry to expand into new markets and elevate the value of their products, processes, and quality management systems. From startups to international industry giants, we provide clients with a single point of contact for all certification needs, simplifying processes and ensuring seamless compliance. Supported by our global team of experts, we help you navigate the regulatory landscape, unlocking the full potential of your products.

Discover more about our medical device certifications: CE Marking (MDR (EU) 2017/745), MDSAP (Medical Device Single Audit Program), ISO 13485, ISO 15378, TCP III, and more.

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

CE marking

MDR (EU) 2017 / 745

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Classification, Medical Devices, MDR, file,

Understanding the Classification of Medical Devices under EU MDR

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MED unannounced audits

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Change of certifier and/or notified body

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interview-join-dqs-eine geschaeftsfrau macht sich notizen

CE marking: Notes on handling unannounced audits

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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.

 

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

Certification Process and Maintenance for ISO 13485

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Materials selection for medical devices

The Importance of Material Selection in Circular Design of Medical Devices

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

Efficient Supplier Management for Medical Devices Manufacturers

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

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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

Dec 02-06 , 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

Nov 18-19 , 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

On demand
Online or Classroom | English
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Instructor Led Training

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

On demand
Online or Classroom | English
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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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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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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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ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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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

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.

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MDSAP Audit Approach Enhancing Supplier Selection in Purchasing

MDSAP Audit Approach: Enhancing Supplier Selection in Purchasing

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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

Dec 02-06 , 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

Nov 18-19 , 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

On demand
Online or Classroom | English
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Instructor Led Training

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

On demand
Online or Classroom | English
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Event

MDSAP Overview Training

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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

Primary packaging materials for medicinal products

ISO 15378

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Change of certifier and/or notified body

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Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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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

Dec 02-06 , 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

Nov 18-19 , 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

On demand
Online or Classroom | English
Read more
Blog

ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

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

MED unannounced audits

Read more
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

Read more
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

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