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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# MDSAP- Medical Device Single Audit Program # Health care cer­ti­fic­a­tions # Primary pack­aging ma­ter­i­als for medi­cin­al products # CE marking # ISO 13485

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

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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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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Product
EN ISO 13485
Quality management systems for medical devices
Product
Regulation MDR (EU) 2017/745
CE marking for medical devices
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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Change of certifier and/or notified body

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CE marking

MDR (EU) 2017 / 745

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen

MED unannounced audits

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

Change of certifier and/or notified body

Read more
Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen

CE marking: Notes on handling unannounced audits

Read more
Product
Regulation MDR (EU) 2017/745
CE marking for medical devices
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.

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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

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