Medical device inspections

Name: Medical device inspections
Creator: Swiss Agency for Therapeutic Products
Keywords: actions,guidances,inspection,markets,medical-devices,requirements,surveillance

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Market Surveillance

Last updated

February 1, 2024

Description

Document focuses on medical device inspections with a specific emphasis on market surveillance.

Organization

Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

Country / Region

Switzerland

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

8 Main files

Inspektionen Medizinprodukte

Updated on February 23, 2024

html

URL: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/marktkontrolle-medizinprodukte/inspektionen-bei-marktakteuren.html
Permalink: https://data.openrid.co/en/datasets/r/756ddf88-b4fd-4343-938b-2dc6fa311c45
MIME Type: text/html

Created on: February 23, 2024
Modified on: February 23, 2024

IN640_00_001d_MB Merkblatt Anforderungen MDS an Korrekturmassnahmenplan

Updated on February 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/in640_00_001d_mb_anforderungen_capa_plan.pdf.download.pdf/IN640_00_001d_MB_Anforderungen_CAPA_Plan.pdf
Permalink: https://data.openrid.co/en/datasets/r/a6f7543b-6bfe-4b8b-a912-33f5602c8a81
MIME Type: application/pdf

Created on: February 1, 2024
Modified on: February 1, 2024

Medical device inspections

Updated on February 23, 2024

html

URL: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/inspections-of-market-participants.html
Permalink: https://data.openrid.co/en/datasets/r/eacd6621-a3f3-458c-aa3c-3da9d280e9b4
MIME Type: text/html

Created on: February 23, 2024
Modified on: February 23, 2024

IN640_00_001e_MB Information sheet MDS requirements for corrective and preventive action plans

Updated on February 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/in640_00_001d_mb_anforderungen_capa_plan.pdf.download.pdf/IN640_00_001e_MB_Requirements_CAPA_Plan.pdf
Permalink: https://data.openrid.co/en/datasets/r/36aca417-717f-4b1a-afd2-2d86a5023f43
MIME Type: application/pdf

Created on: February 1, 2024
Modified on: February 1, 2024

Ispezioni nel campo dei dispositivi medici

Updated on February 23, 2024

html

URL: https://www.swissmedic.ch/swissmedic/it/home/dispositivi-medici/controllo-del-mercato-dei-dispositivi-medici/ispezioni-presso-operatori-del-mercato.html
Permalink: https://data.openrid.co/en/datasets/r/3fbf036b-f001-4216-a469-8c0e1ce07aac
MIME Type: text/html

Created on: February 23, 2024
Modified on: February 23, 2024

IN640_00_001i_MB Scheda informativa Requisiti per i piani CAPA relativi ai dispositivi medici

Updated on February 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/in640_00_001d_mb_anforderungen_capa_plan.pdf.download.pdf/IN640_00_001i_MB_Requisiti_Piano_CAPA.pdf
Permalink: https://data.openrid.co/en/datasets/r/f0655fdb-83e9-4d1a-81c9-830a30d6853b
MIME Type: application/pdf

Created on: February 1, 2024
Modified on: February 1, 2024

Inspections dans le domaine des dispositifs médicaux

Updated on February 23, 2024

html

URL: https://www.swissmedic.ch/swissmedic/fr/home/dispositifs-medicaux/controle-du-marche-des-dispositifs-medicaux/inspections-des-acteurs-du-marche.html
Permalink: https://data.openrid.co/en/datasets/r/42508466-7fcf-4c2a-93a9-704dfc984592
MIME Type: text/html

Created on: February 23, 2024
Modified on: February 23, 2024

IN640_00_001f_MB Aide-mémoire Exigences concernant les plans CAPA relatifs aux dispositifs médicaux

Updated on February 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/in640_00_001d_mb_anforderungen_capa_plan.pdf.download.pdf/IN640_00_001f_MB_Exigences_Plan_CAPA.pdf
Permalink: https://data.openrid.co/en/datasets/r/2883bfc4-6281-4ab5-8ba0-b9e3923040a2
MIME Type: application/pdf

Created on: February 1, 2024
Modified on: February 1, 2024

Medical device inspections

Information

Type

Regulated products

Topics

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed