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.

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.

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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CE marking: Notes on handling unannounced audits

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Change of certifier and/or notified body

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MED unannounced audits

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.

 

Primary packaging materials for medicinal products

ISO 15378

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Change of certifier and/or notified body

CE marking

MDR (EU) 2017 / 745

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CE marking: Notes on handling unannounced audits

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Flatten-the-Curve? From 2023, the big wave of MDR certifications will be rolling in for notified bodies

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Change of certifier and/or notified body

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MED unannounced audits