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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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# MDR (EU) 2017/745 (CE Marking for Medical Devices) # ISO 13485 # MDSAP - Medical Device Single Audit Program # ISO 15378

MDR (EU) 2017/745 (CE Marking for Medical Devices)

Certification for Medical Devices in the EU Market

As of May 26, 2021, the Medical Device Regulation (MDR) (EU) 2017/745 has heralded a new era for medical device companies operating within the European Economic Area (EEA). This regulation has replaced both the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). With an unwavering focus on patient safety and product efficacy, the MDR establishes rigorous standards and conformity assessment procedures that companies must adhere to before bringing their devices to market in the EEA. Discover what requirements you need to access the European market by clicking below.

Learn more about the Medical Device Regulation (MDR) (EU) 2017/745

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

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

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PSUR for Medical Devices under EU MDR: Preparation and Submission

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Key Objectives and Content of a Periodic Safety Update Report (PSUR)

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Understanding Periodic Safety Update Reports (PSUR) for Medical Devices

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How the Approval of Medical Devices is Changing in Europe, the USA, and Other Markets

Medical Device Approval Changes in Europe, USA, and Global Markets

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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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CE marking: Notes on handling unannounced audits

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Price list of standard fees for the MDR

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Product
ISO 15378 Certification
Discover how ISO 15378 certification ensures the safety and quality of pharmaceutical packaging for manufacturers in countries like South Africa, Namibia, Zambia, and Botswana. Improve patient safety and meet global standards with DQS.
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

The standard for reliable medical solutions

The ISO 13485 standard outlines the requirements for a quality management system necessary for organizations to supply medical devices and/or related services. These organizations may be involved in various stages of the product life cycle, such as design, production, distribution, installation, or servicing of medical devices, as well as associated activities like technical support. The main benefits for the companies include identifying areas for optimization in your quality management system, leading to cost savings, risk reduction, and increased customer satisfaction.

Get more information about ISO 13485

 

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

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

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How the Approval of Medical Devices is Changing in Europe, the USA, and Other Markets

Medical Device Approval Changes in Europe, USA, and Global Markets

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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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The Importance of Material Selection in Circular Design of Medical Devices

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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

Mar 10-14 , 2025, 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

8575 Rand (ZAR)
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

Jan 27 , 2025, 08:00-16:00
Online or Classroom | English
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Instructor Led Training

ISO13485:2016 Hybrid Training

8800 Rand (ZAR)
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 To Ensure Safety and Quality Throughout the Product Lifecycles

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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
The Internationally-Recognised Quality Management System for Medical Devices
Product
ISO 15378 Certification
Discover how ISO 15378 certification ensures the safety and quality of pharmaceutical packaging for manufacturers in countries like South Africa, Namibia, Zambia, and Botswana. Improve patient safety and meet global standards with DQS.
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

MDSAP - Medical Device Single Audit Program

One Audit, Five Markets

The Medical Device Single Audit Program (MDSAP) enables medical device manufacturers to qualify for multiple markets with a single audit: Australia, Brazil, Japan, Canada, and the USA. The benefits of the program extend beyond the recognition of results for medical device registration, including the reduction of on-site inspections by participating authorities and related costs.

Discover more about MDSAP

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

International Medical Device Regulators Forum (IMDRF)

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

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

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Blog
How the Approval of Medical Devices is Changing in Europe, the USA, and Other Markets

Medical Device Approval Changes in Europe, USA, and Global Markets

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MDSAP Audit Approach Enhancing Supplier Selection in Purchasing

MDSAP Audit Approach: Enhancing Supplier Selection in Purchasing

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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

Mar 10-14 , 2025, 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

8575 Rand (ZAR)
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
Read more
Instructor Led Training

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

Jan 27 , 2025, 08:00-16:00
Online or Classroom | English
Read more
Event

MDSAP Overview Training

On demand
Online | English
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Blog
header-join-dqs-ein mann spricht mit dem team

Change of certifier and/or notified body

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Product
ISO 15378 Certification
Discover how ISO 15378 certification ensures the safety and quality of pharmaceutical packaging for manufacturers in countries like South Africa, Namibia, Zambia, and Botswana. Improve patient safety and meet global standards with DQS.
Product
MDSAP Medical Device Single Audit Program
Medical devices in the international environment

ISO 15378

Primary Packaging Materials for Medicinal Products

ISO 15378 applies to manufacturers of primary packaging materials that come into direct contact with pharmaceutical products. The standard covers all common materials used for primary packaging, such as glass, rubber, aluminium, and plastics. All contract manufacturers of these materials or manufacturers who package pharmaceutical products themselves can ensure early compliance with high GMP standards and international acceptance with ISO 15378. For suppliers of primary packaging materials for pharmaceutical products, the standard includes all relevant GMP requirements and enables compliance with international, European, and national legal guidelines.

Gain more insights into ISO 15378

Blog
How Can You Improve Efficiency and Maximize Safety with ISO 15378

How to Improve Efficiency & Ensure Safety in Pharmaceutical Packaging Manufacturing

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Change of certifier and/or notified body

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