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Medical devices



We are a certification company and notified body with over 20 years of experience in leveraging quality within the medical devices industry—personalized, 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 our clients 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 # 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
Header Blog TD under MDR - Common Mistakes

Technical Documentation for Medical Devices Under MDR: Common Mistakes

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

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

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Team Unity Friends Meeting Partnership Concept

PSUR for Medical Devices under EU MDR: Preparation and Submission

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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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Why a QM Manual is Key for High-Quality Standards?

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Classification, Medical Devices, MDR, file,

Understanding the Classification of Medical Devices under EU MDR

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Webinar

EU MDR Transition Timelines – Impact on Manufacturers

Online | English
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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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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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Regulation MDR (EU) 2017/745
CE marking for medical devices
Product
MDSAP Medical Device Single Audit Program in India
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 informations about ISO 13485

 

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

CAPA for Medical Devices in India : 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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Blog
Blog - ISO 13485 - Certification Process and Maintenance for ISO 13485

Certification Process and Maintenance for ISO 13485

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Blog
Blog Risk Management in Medical Devices

Risk Management for Medical Devices

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Blog
What is a quality management manual picture document cloud blog

Why a QM Manual is Key for High-Quality Standards?

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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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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 Certification in India
Quality management systems for medical devices
Product
MDSAP Medical Device Single Audit Program in India
Medical devices in the international environment

MDSAP

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 in India : 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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Blog
MDSAP Audit Approach Enhancing Supplier Selection in Purchasing

MDSAP Audit Approach: Enhancing Supplier Selection in Purchasing

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Blog
What is a quality management manual picture document cloud blog

Why a QM Manual is Key for High-Quality Standards?

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Event

MDSAP Overview Training

Online | English
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DQS MED presentation slides

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Change of certifier and/or notified body

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Product
MDSAP Medical Device Single Audit Program in India
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, aluminum, 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

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DQS MED presentation slides

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Change of certifier and/or notified body

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