How to use Harmonized Standards for Medical Devices?

Medical Device made Easy Podcast

Вміст надано Monir El Azzouzi. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Monir El Azzouzi або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.

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miniature episode 297 How to use Harmonized Standards for Medical Devices? Beat Keller from SMDC Monir El Azzouzi easy medical Medical Devices

Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly.

Who is Beat Keller?

Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.

Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link

Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/
SMDC website: https://www.smdc.ch
EU IVDR harmonized standards: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en
Swiss harmonized standards: https://www.switec.info/de/neue-harmonisierte-normen/
US FDA Recognized Consensus Standards: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

episode 297 How to use Harmonized Standards for Medical Devices? Beat Keller from SMDC Monir El Azzouzi easy medical Medical Devices

The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

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