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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# CE marking # MDSAP- Medical Device Single Audit Program # Primary pack­aging ma­ter­i­als for medi­cin­al products

CE marking

MDR (EU) 2017 / 745

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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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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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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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The Passport to the Medical World: Unlocking Global Medical Device Markets

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European Parliament Passed Proposal to Extend MDD

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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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Regulation MDR (EU) 2017/745
CE marking for medical devices
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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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Post-Market Surveillance and Vigilance: Requirements for MDSAP

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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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MDSAP Audit Approach Enhancing Supplier Selection in Purchasing

MDSAP Audit Approach: Enhancing Supplier Selection in Purchasing

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

Change of certifier and/or notified body

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