What if your Medical Device company goes Bankrupt?

This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You still have some responsibility and the EU MDR is asking you to put in place some process to anticipate that. This is what we will discuss with Karandeep Badwal today. We'll try to give you some advice on how to overcome this situation.

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► Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

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► Who is Monir El Azzouzi?

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► Links from the Video

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► Social Media to follow

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#easymedicaldevice #medicaldevice #regulatorycompliance

[FranFumanal]

Thank you Monir El Azzouzi & Karandeep Badwal for this amazing podcast and topic. As you pointed, it is clear the requirement but not that much how to deal with it in the event of a bankrupcy real scenario. Further than your thoughts, like specific agreements with the insurance company, AR, ... What I clearly miss in the podcast although referred in somehow (like in the event of a complaint, investigation, recall, and so on, with the PRODUCT), is what it happens with the stock of product which has been released, and therefore placed, e.g. on the market (like in the warehouse of a distributor). Should they stop selling these devices? The fact is the device, when was placed on the market, was perfectly LEGAL (compliant with the legal requirements), but how the CE associated with the devices may be still "applicable" as long as no NB will be taking care, e.g. of the surveillance, or even worst, how to deal in the scenario of a MDD CE with the transition period as per Regulation EU 2023/607. Have you considered all these? Your comments are deeply appreciated. Thank you in advance. Keep doing as usual, you, guys are amazing!

[alexandros.savvidis]

Thank you Karandeep for the Good Input, how often we see that important decisions are taken from Marketing Persons where they dont understand maybe the deeper responsibilities for medical products still running on the Market. I really appreciate Marketing people and like to exchange often with they but sometimes i realise that they implement QA RA strategies too, maybe without previous clarifications with specialists and this can be off course dangerous! I meet already cases of completely wrong procedures not for bankrupt but for end of life discontinuation of the Product, They wanted with one internal agreement to stop the Product from Market without other thoughts. We should highlight that it is dangerous. Always please take advise of one QA RA Specialist what to do as long one product is still on the market!