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.  Regulatory intelligence seems to be a big scary word that people may think it needs a ton of experts to be able to master it. But with digitalization this needs less efforts now. When before you needed to check a lot of journals or visit a lot of country websites, now there are tools that helps you do it quicker. This is mainly the topic of our di ..read more

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. 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 havi ..read more

This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation… So if you want to avoid these issues don’t miss this episode as they can cost you time and money. Who is Adam Isaacs Rae?  Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lea ..read more

Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step but for the moment a lot of the products we see are relying on the EU rules. But UKCA is about to be the rule. I mean we thought this will be the rule but apparently there are new timelines coming.   So let’S discuss that with Claire Dyson  Who is Claire Dyson?  Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bo ..read more

We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster. Waterfall? Agile? … The methodology to develop a Software are multiple but you need as a company to define it prior to the project so you have the right pathway to follow. And in this episode of the podcast we will help you transition to the AGILE methodology for Software development. This is a well known method but we’ll try also to explain its advantages and also look at the way for you to trans ..read more

If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal.  An Audit is really an exercise that all Quality and Regulatory people should understand to master it. See it as a performance on stage, or a sport competition. Before it happens, you should prepare yourself. We will discuss on this episode with Karandeep Badwal of the way that you should be preparing and the tips and tricks that you will need to know. Internal audit, CE audi, ISO au ..read more

Today on this Medical Device news for March 2023 we’ll talk about • The EU MDR Extension vote • The Notified Bodies that are certified • The changes in EU spain, UK, Switzerland, Belgium • But also Middle East, USA, Brazil. ——————————————————————————————————- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now c ..read more

In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book “Safety Risk Management for Medical Devices”. If you have to perform risk management for a software as a Medical Device or Medical Device software you may think how this can be done?, Are the tools, standards, the same as for normal medical devices? Are the risks different? Bijan Elahi will be my guest on this episode and will explain to us the best practices for SaMD risk management. Don’t miss this and also his book called “Safety Risk ..read more

The EU MDR is requiring more transparency and the PMS has a lot to play in it. In this episode, we will explain to you a difference that is visible for PMS which is Proactive Postmarketing Surveillance. We will explain what they mean by that and how some digital tools can help you. Who is Marcus Emne? Marcus Emne is the CEO & founder of Hoodin, the intelligence SaaS for life science & compliance. Marcus has extensive experience in international business from both high tech, software and life sciences. Over the last years, he has had a focus on intelligence and the subdomains Ai, Autom ..read more

Vigilance Reporting is a process you should have but don’t want to use. In fact not having any vigilance reporting is a sign that your product is doing well. But having one means that maybe you need to improve your device.   So in this episode, we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reporting, the UK, but also other regions. We will also mention IMDRF guidances that are important. Who is Adam Isaacs Rae?  Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University ..read more