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Medical devices



DQS Medizinprodukte GmbH offers various services in the field of approval of medical devices and certification of management systems in healthcare. With our competence, experience and range of services, we can give you a real competitive edge. The value of and trust in our certificates are essential for us and our customers. We stand by this with our commitment to impartiality and independence in the performance of our certification activities.

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# ISO 13485 # MDSAP- Medical Device Single Audit Program # Primary pack­aging ma­ter­i­als for medi­cin­al products

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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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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Blog Risk Management in Medical Devices

Risk Management in the Medical Device Industry

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What is a quality management manual picture document cloud blog

Why a QM Manual is Key for High-Quality Standards

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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
EN 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.

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

International Medical Device Regulators Forum (IMDRF)

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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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Blog - MDSAP - PMS and MDSAP

Post-Market Surveillance and Vigilance: Requirements for MDSAP

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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
What is a quality management manual picture document cloud blog

Why a QM Manual is Key for High-Quality Standards

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

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

Change of certifier and/or notified body

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