EU

Manual on Borderline and classification for Medical Devices Update - New entries to the file: [ Ссылка ]
Q&A on Annex XVI Products - Check transition timeline: [ Ссылка ]
Italy: Custom-made medical device registration - Specific website available: [ Ссылка ]
Ireland: Custom-made device Webinar October 19th, 2023 - Webinar to join: [ Ссылка ]-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0
Team-NB - Training on MDR Technical Documentation for Manufacturers - Date of the event November 7th, 2023: [ Ссылка ]
Technical Documentation template Premium Pack: [ Ссылка ]
FIMEA designate first Notified Body under the IVD regulation in Finland - EUROFINS Electric & Electronics Finland Oy: [ Ссылка ]

UK

The innovation Devices Access Pathway (IDAP) - Pilot Phase to join - Answer before October 29th, 2023: [ Ссылка ]

CH

Swissdamed Survey Report - The EUDAMED for Switzerland to start in 2024:  [ Ссылка ]

Conferences

Which conferences to focus on?  - I will be going to them so join me.
MEDXD: Digitalisation of Medtech: [ Ссылка ]
Afrisummit in Egypt:  [ Ссылка ]
Medica: [ Ссылка ]
Team-PRRC: [ Ссылка ]

Training

Trainings for you - Self-paced
Vigilance Reporting: [ Ссылка ]
Audit Readiness: [ Ссылка ]

US

US FDA - De Novo Request - Electronic Submission template: [ Ссылка ]

Webinar US FDA - Cybersecurity in Medical Devices: - November 2nd 2023: [ Ссылка ]
Webinar US FDA  - Breakthrough devices program update - November 14th, 2023: [ Ссылка ]
Digital Health FAQ - Is your medical device an SaMD?: [ Ссылка ]
ISO 10993-1:2018 versus FDA - FDA is adding its touch: [ Ссылка ]
Best practice for selecting a Predicate device for your 510K - Method provided. [ Ссылка ]

Saudi Arabia

SFDA Significant changes guidance - Template inside: [ Ссылка ]

Malaysia

Malaysia: Workshop preparation of documents for Submission -  October 23rd, 24th and 30th: [ Ссылка ]

Turkey

Mutual Recognition of Authorized rep and NB in Turkey - Good clarification:  [ Ссылка ]
Japan: Essential Principles - In 2023 inclusion of the Cybersecurity risks: [ Ссылка ]

India

India: List of registered medical device testing laboratory - under Indian mdr 2017: [ Ссылка ]=

Podcast

Podcast Nostalgia - Do you remember?
Episode 249: Team-PRRC interviews part 1 : [ Ссылка ]
and 250: part 2: [ Ссылка ]
Episode 251: EUDAMED Updates: [ Ссылка ]

QMS

How Easy Medical Device can help you -easymedicaldevice.com
We can also help you implement our eQMS - Smarteye: [ Ссылка ]

► Social Media to follow

■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]

#easymedicaldevice #regulatorycompliance

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