In this video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” Transcript: In today’s video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” In the latest 2020 version,
What is the harmonized standard? Last month, we discussed clinical evaluation and clinical investigation, during which we also touched on the ISO14155:2020. This month, we’re going to dive into this even further. The ISO14155:2020 is recognized as an harmonized standard. In accordance with Article 5(1) of the Council Directive, all EU member states should aim to follow certain
In this video the top 3 general differences and improvements between the MDR and the previous Directives related to clinical investigations are given. Looking for In-Depth ISO14155:2020 training? Have a look at the e-learning at the academy. Transcript: In today’s video I’m going to answers the following question: “What are the general
This week FAQ video is about the clinical requirements under the MDR. Would you like to know more about the differences between clinical evaluation and clinical investigation? Have a look at the article I wrote about this. Transcript: Good morning everyone, From my camper at my holiday, I would like to give you
In this video the major changes to the regulatory submission in the Netherlands of clinical investigations is given. Transcript: These 6 key changes to the regulatory application in the Netherlands under the MDR are: The CCMO will be the competent authority for clinical investigations. A separate notification to the Health and Youth care Inspectorate
You know by now what a medical device is; you’ve seen them, you’ve read about them, they stand to be one of the greatest medical inventions of our time. But, how does it come to life? Which processes are involved when placing a medical device on the market? A medical device follows a detailed set
In this video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” Transcript: In today’s video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” In the latest 2020 version,
What is the harmonized standard? Last month, we discussed clinical evaluation and clinical investigation, during which we also touched on the ISO14155:2020. This month, we’re going to dive into this even further. The ISO14155:2020 is recognized as an harmonized standard. In accordance with Article 5(1) of the Council Directive, all EU member states should aim to follow certain
In this video the top 3 general differences and improvements between the MDR and the previous Directives related to clinical investigations are given. Looking for In-Depth ISO14155:2020 training? Have a look at the e-learning at the academy. Transcript: In today’s video I’m going to answers the following question: “What are the general
This week FAQ video is about the clinical requirements under the MDR. Would you like to know more about the differences between clinical evaluation and clinical investigation? Have a look at the article I wrote about this. Transcript: Good morning everyone, From my camper at my holiday, I would like to give you
In this video the major changes to the regulatory submission in the Netherlands of clinical investigations is given. Transcript: These 6 key changes to the regulatory application in the Netherlands under the MDR are: The CCMO will be the competent authority for clinical investigations. A separate notification to the Health and Youth care Inspectorate
You know by now what a medical device is; you’ve seen them, you’ve read about them, they stand to be one of the greatest medical inventions of our time. But, how does it come to life? Which processes are involved when placing a medical device on the market? A medical device follows a detailed set
