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Technical Documentation for Medical Devices - Johner …
- https://www.johner-institute.com/articles/regulatory-affairs/and-more/technical-documentation/
- Regulatory requirements for the technical documentation. a) Medical Device Directive …
Design Dossier | Greenlight Guru
- https://www.greenlight.guru/glossary/design-dossier
- The purpose of a design dossier is to facilitate a design examination by a Notified Body whose goal is to verify that your medical device conforms to its technical specifications. When these design examinations are …
Contents of a Dossier | WHO - Prequalification of …
- https://extranet.who.int/pqweb/vitro-diagnostics/contents-dossier
- Contents of a Dossier. determine whether the manufacturer's quality management system is of an adequate standard to warrant a site inspection. product performance specification, …
Contents of a Dossier | WHO - Prequalification of …
- https://extranet.who.int/pqweb/contents-dossier
- Device description. The dossier should include the following device descriptive information: A general description including its intended use/purpose. The intended patient population …
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