Medical Device made Easy Podcast
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HOT TOPICS
Europe
Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
Reclassification of groups of certain active products without an intended medical purpose
Updated information pack for candidate EU reference laboratories published
51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD))
MDCG 2022-16: Guidance on Authorised Representatives Regulation
New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic)
Training
December 12th until December 16th https://school.easymedicaldevice.com/product/gb
UK MHRA: Borderline products: how to tell if your product is a medical device: New section added ‘Risk classification of medical devices’
Swissmedic: Plan to accept FDA products in Switzerland
Finland: Power blackouts do not require special preparedness measures from the users of medicines and medical devices
Rest of the world
United States: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox)
United States: MedSun Newsletter – November 2022
Canada: List of recognized standards for medical devices:
Canada: November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting
Bahrain: Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration
If you are looking for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com
PODCASTS:
The post Medical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Summative Evaluation – Common mistakes
Are you more Corrections or Corrective Actions or Preventive Actions?
How to select and evaluate your Contract Manufacturer?
Quality Field Service for Medical Devices
Medical Device NewsMAY 2024 Regulatory Update
Why and how to build a Quality Culture?
What is the impact of AI Act on Medical Devices?
Radiation Sterilisation Master File (ISO 11137 & 11607)
Medical Device News April 2024 Regulatory Update
How to benefit from Surveys to build Clinical Evidence?
How to do Postmarketing Surveillance the right way?
Learn more about FDA QMSR alignment with ISO 13485
Medical Device News March 2024 Regulatory Update
New EU Proposal – EUDAMED, IVDR & Shortage
Will EtO gaz become a Medical Device?
How to get your interview prepared?
Medical Device News february 2024 Regulatory Update
Why you should use Pre-Submission or Q-Sub with FDA?
You are not the Physical Manufacturer, can you be MDR certified?
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
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