Відео

Thanks for your videos! I'm new to this kind of regulatory documentation, but your content helps me out a lot :) I'm just curious about the conclusion here: Obviously, your video points out that shipping your Jira/trello/whatever tickets / Github issues & PR discussions etc. as documentation for your medical software is not an option. But both can still be done in parallel right? an Agile board / issue tracker for developers, and the documentation for regulation. I mean taking your example here, a milestone could be added to the basecamp ticket, and the output of that ticket would not only be to perform the change in the software, but also to update the documentation accordingly..? In a previous project, each issue had a checklist that needed to be fulfilled for that particular issue to be closed: 1. Provide possible solutions + chosen solution for the fix 2. Implement the fix 3. Provide 100% test coverage 4. Update project requirements Then the next release in which the fix is implemented matches the project documentation. Would this workflow work?

Sehr gut, danke.

In some cases, you may find a "pure" ISO standard that does NOT have a corresponding EN ISO standard. In this case, the EVS pricing for the "pure" ISO standard is similar to the higher ISO standard prices you will find from other standards bodies and standards resellers.

A quick comment (correction) that even further supports acquiring standards from EVS. The lower-priced standards sold by EVS are not the "pure" ISO versions - instead, they are "EN ISO" standards that include the ISO standard inside and also include bonus material applicable to European regulations. The bonus information are called "Z" Annexes that correlate the clauses of the standard to the corresponding General Safety and Performance Requirements (Annex I) of the Europe MDR and IVDDR.

Hello Oliver, you mentioned that it is ok (desirable) to overwrite old records with new records. That has not been my experience in my many years of designing, running and auditing medical device quality systems. From my perspective, all records should be dated and saved "forever". It is normal to have new records but I would not want to overwrite an older record with a newer record. Perhaps you can clarify your meaning?

I agree that EVS (Estonia national standard body) is the most affordable source in the world for "EN ISO" versions [or "EN" versions associated with IEC standards - not called EN IEC typically - weird]. But please note that their prices for the "ISO" only versions of standards is similar to other standards bodies and resellers. So buy EN ISO or EN (IEC) standards from EVS and you get the ISO/IEC version inside the document and also get informative European Z Annexes that map the clauses of the standard to the corresponding European medical device regulations, formerly the European Directives.

Very wholesome tutorial. I love this feature! Thank you.

Great content; thanks!

can this SW create test cases with already available requirement document? so can we upload our own req. document and it can generate module test cases or system level test cases?

Great to see promotion of EVS - simple and relatively easy to use, they don't over-sell themselves and spam you with emails. Software restrictions like 'FileOpen' are overburdening, particularly for smaller companies and start-ups. EVS also offer free tracking/notification for new standards - you just need an account and don't have to buy the standard beforehand. I think other companies charge for similar services.

Oliver you are a legend. what do you think of a similar idea using a Modern Requirements plugin in DevOps for example?

Easing the burden of bureaucracy is cool!

Great Business and Work! Thanks for your Mission! Looking forward to dig those files and maybe also receive consultancy from you. Keep it up!

Does it have ISO 9001 templates?

helpful video! i would like check if we have one device with 5 variants (difference in size) , do we need to buy 5 UDI-Di?

cool! Thank you

Such a cool feature. Looking forward to begin with the risk management process in Formwork.

spät gesehen, aber finde ich jetzt auch noch Klasse !

github was started in 2008 , before that sourceforge was the place where opensource project were hosted when a project was not hosted on a specific server

Nice job

Could your software take existing documentation and rewrite it - simplify and correct ?

Does framework integrate with jira, so if you raise a ticket within jira can it link into framework

Have you found a perfect way for Agile to work with 62304 yet?

Will the AI do its own literature search for writing a scientific article in the style of Nature Immunology, or do I need to input a bibliography?

Thank you for this information How can we obtain the forms for the internal audit of the quality management system and all of you for the management review

Sure AI can do it

I noticed that you entered the version for jQuery as 3.4.1, however in the package.json it's ^3.4.1, which is 3.4.1 or above. Will this cause issues come audit time?

You guys should add an upload feature, wherein you can upload doc files or xls files and they are automatically converted into documents on your site. Making/Copying the entire document on your site again is unnecessary.

Thanks for sharing this! A question: any first level dependency depends on a number of second level ones, and those on more dependencies and so on. Any mid-sized rails project can have a few hundred dependencies when you sum all up, and it gets way uglier if you take the node route ... ... are all those considered SOUP? I mean, why would they not be considered as such? Of course, if first level SOUP as you describe is pain, a positive answer to that question would mean insurmountable unbearable agonizing pain. There is probably lower levels in hell to the one when you get to list all the requirements of your node_modules folder ... but not many :) So, what do you think?

Very informative.

Regarding the anomaly list: I believe it is enough to filter the list for entries for bugs, which is usually possible using labels or other filter operations.

You are a gentleman and a scholar

Sehr sympathischer und interessanter Vortrag. Und eine super Initiative Oliver!