Recent Posts
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Validation of Quality Software in Medical Devices
Software validation when used on patient is common and mandatory. But now when we tell you that you should validate also the software you are using to record your documents, CAPAs, or work on the elements related to the product, then this start to be a bit tricky. Medical Device companies are not used to such requirements and we will explain how they should proceed on this podcast.
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How to register Medical Devices in Saudi Arabia?
Saudi Arabia is a major actor in the Medical Device world. A lot of companies are willing to enter this market that can help them to reach also other regions of the Middle East. We will discuss with Ahmed Hendawy from Registitute about the way to register your medical devices with SFDA authorities.
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What should you know on UKCA extension
UK decided to add more time to implement the UKCA. Apparently, the EU amendment to extend the EU MDR and IVDR was also something they looked at to define their timeline. So, let’s see what will this mean for manufacturers with Alex Denoon, partner at the law firm Bristows.
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How to connect Software dev and QA RA Team
You may be on the business of Software development and you ask yourself why your Dev team is not really happy to work with Quality and Regulatory affairs team? In this episode, we will discuss with Christophe Girardey from WEGA about the gaps and how this can be solved.
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The great misunderstanding of EU MDR amendments
Since the EU MDR extension was voted, there are still a lot of questions remaining. This is what we will try to clarify today with Florian Tolkmitt from Pro-Liance. This podcast will provide you some tips or help you avoid some great misunderstanding.
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How to master Regulatory Intelligence?
We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search.
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What if your Medical Device Company goes Bankrupt?
I know this is not really something that people anticipate. But the EU MDR is asking you to anticipate that. So don’t miss this as this can raise a Non-Conformance from the Notified Body during an audit if there is no plan in place. So do check what we propose to you.
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Technical Files Inconsistencies Identified by Notified Bodies
Technical Files inconsistency, it is when your technical file is not providing the right information or that all the information is not aligned. Here we will try to look at some of these issues.
