Happy New Year Dear Monir, The Difficulty of Viability of a fresh NB> Having discussed with some Fresh Nbs about theit worries, are the very high costs first to get accredited then secondly to find customers is not easy bc they dont cover many mdr ivdr codes groups , imagine now high exposition presence, advertisment costs, their consultants team is small in the begin, practically small capacities to support multiple customers. Manufacturer's which find capacities there, are a little worried bc there is no so much experience about hot topics. So High running costs, less income and somewhere start the busines to be very risky, it can be reason to go in bankruptcy. In short form you reach one peak of costs where You have really to earn some money to stay alive. We have also cases where customers wants to bring a NB under the law due to delayed response which guides to their fincancial difficulties.

I really appreciate your efforts! Just a quick off-topic question: I have a SafePal wallet with USDT, and I have the seed phrase. (alarm fetch churn bridge exercise tape speak race clerk couch crater letter). Could you explain how to move them to Binance?

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I congratulate you for your contribution to the medical device industry. The information you have shared with us has always been useful, you have enabled me to learn and realise many things. I send my good wishes for 2025. Happy New Year

Thank you so much for this amazing video! I need some advice: My OKX wallet holds some USDT, and I have the seed phrase. (alarm fetch churn bridge exercise tape speak race clerk couch crater letter). Could you explain how to move them to Binance?

Appreciate the detailed breakdown! Just a quick off-topic question: My OKX wallet holds some USDT, and I have the seed phrase. (alarm fetch churn bridge exercise tape speak race clerk couch crater letter). What's the best way to send them to Binance?

You're doing a fantastic job! Just a quick off-topic question: I have a SafePal wallet with USDT, and I have the seed phrase. (alarm fetch churn bridge exercise tape speak race clerk couch crater letter). How should I go about transferring them to Binance?

Thanks for indetailed explanation for clinical data collections...great conversation

Thanks Munir, would you please arrange an episode about shelf life and shelf life extensions for MD products that need this requirements, such as those under MDR rule 21?

Thanks Mr. Adnan

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It helps me to understand the definition of accessory and medical part/component，but still, if an accessory is regulated by mdr, should it be in the same class with my main device? what should I put on the lables ? What certificate should NB give me if it is not a medical device?

Thanks for the breakdown! Could you help me with something unrelated: My OKX wallet holds some USDT, and I have the seed phrase. (alarm fetch churn bridge exercise tape speak race clerk couch crater letter). What's the best way to send them to Binance?

Fantastic episode thank you very much

interesting info

Appreciate the detailed breakdown! Just a quick off-topic question: I have a SafePal wallet with USDT, and I have the seed phrase. (alarm fetch churn bridge exercise tape speak race clerk couch crater letter). What's the best way to send them to Binance?

Thanks Monir

Hello, thank you for this very useful video. I understand that user surveys in PMCF cannot be used to demonstrate anything in clinical evaluation. But what about user surveys for DMs with an indirect clinical benefit for the patient and an Article 61(10) pathway (inappropriate clinical data)? would it be appropriate to provide clinical evidence on performance for a subsequent version of the DM, for example?

how are you?

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👏🏿👏🏿👏🏿👏🏿

Could the blog post link be shared?

UFMEA covers the risk due foreseeable misuse

how are you?

It's refreshing to hear this message, and its title. I have also been fighting this particular fight for two decades. Some people are quite surprised....others are quite defensive!

what is gru yapping about

Hi Munir, thank you for keeping us updated on medical device topics, and for the informative blog posts that provide further clarification on these subjects.

In order to eliminate the possible problems that may arise in terms of data security and responsibility arising from the situations where the peoplewho perform medical device document and product registration transactions on behalf of the companies in the Product Tracking System (ÜTS) in the “Manufacturer/Importer/Dealer/Exporter” and “Custom-made orthotic prosthesis center” company types are not the direct employees of the companies, software development has been completed in the ÜTS system so that a person can be defined as a company user in a maximum of 10 companies for the specified company types and will be implemented with the first version update.

I encounter problems to find a notified body for a start up.

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Hi Monir and Adam, could you please clarify if Article 10a of (EU) 2024/1860 applies in cases where there are similar products from different manufacturers for the anticipated shortage or discontinuation of that specific medical device brand?

Hi, good day sir Can I have a little discussion with you?

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Georg is THE foremost CAPA content creator on LinkedIn...possibly on all of social media! Love the practical examples.

At my company, we do not have a CAPA process or any sort of controlled root cause analysis process, but we have an "Action Plan" form that we use to document any actions resulting from internal audits, management reviews, and customer-related requests. Are we still in compliance with ISO 13485 and the MDR?

how to develop a career as a quality manager of medical devices in UK?

Very nice

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