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

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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medizinprodukte-zertifizierungsdokumente
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Medical Devices Certification Documents

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MED Präsentationsfolien
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Change of certifier and/or notified body

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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medizinprodukte-zertifizierungsdokumente
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Medical Devices Certification Documents

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CE marking: Notes on handling unannounced audits

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MED Präsentationsfolien
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Change of certifier and/or notified body