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

CE marking

MDR (EU) 2017 / 745

Product
Regulation MDR (EU) 2017/745
CE marking for medical devices
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CE marking: Notes on handling unannounced audits

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Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

Product
Regulation MDR (EU) 2017/745
CE marking for medical devices
Product
EN ISO 13485
Quality management systems for medical devices
Blog

CE marking: Notes on handling unannounced audits

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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.

Product
EN ISO 13485
Quality management systems for medical devices

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