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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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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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

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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Change of certifier and/or notified body

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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.

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Change of certifier and/or notified body

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MDSAP Medical Device Single Audit Program
Medical devices in the international environment

Primary packaging materials for medicinal products

ISO 15378

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Change of certifier and/or notified body

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