Відео

Informative session

Thanks for everyone who participated to this Live Session. Next one planned July 19th 2024. Check also the replay if you cannot attend.

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How many notified bodies are in France? Which ones are they?

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Some member states do not have a mechanism for issuing FSC for Article 22 systems... is there any plan to get around this? In Sweden for example Lakemedelsverke (Swedish Medical Products Agency), while not issuing a FSC, do issue a "statement letter" for Article 22 producers.. NL do not have such a process for Article 22 producers

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What’s the difference between Process Validation and Equipment Validation?? How do you define that ??

You are french

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Is Mr. Muhammad Sohail associated with PMD consultancy?

I am the end user of device. I don't know who is the importer ,in this case how can I get this MDMA certificate? How can I contact you sir

Dear Monir to your Question/Call for Comment for the NBs , i can imagine they open Tuev Sued Denmark as independent NB, with its own registration number , they offer specialists talking danish which is important if you visit local medtech companies , but they can use the infrastructure and ressources, SMEs network from Tuev Sued Germany also for specific Topics, their knowledge database, webinars, trainings .That is what i can imagine. Its easier and faster to build one succesful concept of NB , Something similar has happened in the past with BSI having base in Milton Keynes in Uk and Germany Frankfurt parallel 2 NBs with different numbers but there the difficulty was that english speakers had hard to fight in one german talking environment to convince people for changes and bring their opinion through . Or we have Tuev Sued in Turkey for example. Talking local language and having the big advantages of one already established NB brand Name in market is a Very good Concept. Its easier to gain customers like that than starting one NB really from scratch

do you know if there is a possibility to have the AEMPS bulletin in french or english ?

So I need the free sales certificate from the country in which I want to sell my goods? For example the factory is in Thailand and I want to sell the products in Germany then I would need to request a sales certificate from Thailand or Germany ?

Great video. A part 2 that dive deeper into the other alternatives to becoming a legal manufacturer like becoming a distributor or importer would be quite interesting.

Due to costs…Denmark does not charge )or less than Germany) to keep accreditation and for surveillance activities

Great session and very useful

Thank you Monir for making it easier for us to stay up to date with what is new in the MD industry.

To file for NOB opinion upto how many months Validation data shall be required?

Great episode - very recognizable! On the question if quality culture is a (mandatory) requirement based on regulation(s) or quality standard(s) - looking at ISO 13485, there are specific mentions as requirements for this, but it is referred to as 'awareness' instead of culture. It is mentioned in 5.5.2c as part of the role of the management representative to develop within an organization and under 6.2 Human Resources it also includes '..ensuring awareness of personnel' and under part d 'ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives'. Under 5.1 Management commitment part a it lists 'communicating to the organization the importance of meeting customer as well as applicable regulatory requirements'. All of this plays into developing a culture where such requirements are included and considered a normal state of mind within the organization. After having developed our quality management system past year to a level which is fitting to the organization and cooperating with the stakeholders, my next step is having tools in place to raise awareness on regulatory, quality and customer requirements to strengthen the QMS by having the stakeholders understand, in a practical way which makes sense for them, the importance of it all. You also notice 'modern' auditors including it into their audits that they understand any competent Quality Manager can arrange the 'tick in the boxes' for mandatory documentation, but if it is not understood by its users and stakeholders, it will introduce a level of risk of failure which can make your QMS just as ineffective regardless of having documented procedures or not.

For Validation…Upto how many months data is required to file for Technical Documentation review?

Thank you sir ,and do you have FDA medical device regulatory course?My boss want us know it

Hi! I had a quick question about MDCG-1 (MDCG-1-3 to be more specific as we’re dealing with heart implants) and PMS reporting. In the guidance, they give a template table towards the end to show what the report should look like but it looks too simplified for a PMS report. For example, to report individual serious incidents, it seems we’re to report description followed by codes based on Annex E and A. But is that it? Am I to assume that no greater details regarding each incident needs to be provided in the PMS report?