Medical devices



DQS offers various services in the field of approval of medical devices and certification of management systems in healthcare.

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# CE marking # ISO 13485 # 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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Team Unity Friends Meeting Partnership Concept

PSUR for Medical Devices under EU MDR: Preparation and Submission

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

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Unlocking the Business Value of Post-Market Surveillance Beyond Regulations in the Medical Device Industry

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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
Regulation MDR (EU) 2017/745
Approval of medical devices for sale or distribution in the European Economic Area.
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.

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 - 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 for Medical Devices

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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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Blog
Depositphotos_298305132_XL 1.jpg

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

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Blog
Doctor with advanced equipment in hospital ward.; Shutterstock ID 437274070; purchase_order:Kampagne

Unlocking the Business Value of Post-Market Surveillance Beyond Regulations in the Medical Device Industry

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Change of certifier and/or notified body

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Product
ISO 13485 Certification
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.

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 - MDSAP - PMS and MDSAP

Post-Market Surveillance and Vigilance: Requirements for MDSAP

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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
Depositphotos_298305132_XL 1.jpg

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

Read more
Blog
Doctor with advanced equipment in hospital ward.; Shutterstock ID 437274070; purchase_order:Kampagne

Unlocking the Business Value of Post-Market Surveillance Beyond Regulations in the Medical Device Industry

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

Change of certifier and/or notified body

Read more
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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