Medical Device Directive Design Dossier

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Technical Documentation for Medical Devices - Johner …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/technical-documentation/

a) Medical Device Directive 93/42/EEC (MDD) The Medical Device Directive (93/42/EEC) specifies the obligatory requirements for medical devices. Manufacturers are legally …

Medical Device Directive (MDD)

https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf

Design Dossier (DD) The term is only used once in Annex II.4 of the MDD. In layman’s terms, the Design Dossier is the Technical Documentation plus a summary of the history …

Design Dossier | Greenlight Guru

https://www.greenlight.guru/glossary/design-dossier

Here's an overview of how to organize your design dossier for submission: Start with administrative information - include the manufacturer's name and address, the name and location of your EU representative, the file status …

Technical File vs Design Dossier | Greenlight Guru

https://www.greenlight.guru/glossary/technical-file-vs-design-dossier

Medical device companies who wish to sell their devices in the European market must obtain a CE marking by following the procedure for EC Declaration of Conformity outlined in Annex II of the European Medical …

European CE Technical Documentation for Medical Devices

https://www.emergobyul.com/services/european-ce-technical-documentation-medical-devices

CE Technical Documentation Requirements for medical device companies. Your technical documentation includes detailed information about the design, function, composition, …

Technical documentation compared to the MDD - EU MDR

https://eumdr.com/technical-documentation-compared/

On 26 May 2021 the EUMDR entered into application and the MDD was repealed. The Technical Documentation required by the current Medical Device Directive (MDD) is …

Technical Documentation and Medical Device …

https://www.bsigroup.com/contentassets/c48f4dd0aa8d4042987a2fbe72c3e086/white_paper__technical_documentation_web_v3.pdf

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. …

Medical Device Technical File and Its Structure - SimplerQMS

https://www.simplerqms.com/medical-device-technical-file/

Medical Device Technical File Requirements According to the EU declaration of conformity (DoC), the essential rules that your medical devices company …

How to build a Medical Device Technical Documentation …

https://easymedicaldevice.com/technical-documentation/

Fortunately, IMRDF or GHTF created a template called STED (Summary Technical Documentation medical device) to help organize all the information but this was not mandatory per legislation. It was just …

EU Medical Device Directives - 6 Key Elements to Ensure …

https://www.complianceonline.com/resources/eu-medical-device-directives-key-elements.html

Medical devices that don't fall in to the active implantable or IVD type come under the Medical Devices Directive which classifies products according to associated risks: Of the …

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