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[digger2779] 03/6/2020 18:21

Obarmoth - that made me chuckle on a day where I've been let down by everyone and everything.
Tomorrow will be a different story for me but can't speak for FDBK.

[obarmoth] 03/6/2020 16:10

When I die, I'd like the entire management team at Feedback to be my pallbearers.

Just so that they can let me down one last time.

[lr2] 03/6/2020 14:57

Hmm!

'To date, very few radiomics signatures have crossed either of these translational gaps. The first radiology product with radiomics capabilities to receive such approvals was QuantX for detection of breast abnormalities based on MRI, receiving FDA approval in 2017. 77 Soon afterwards, Feedback Medical received CE approval for TexRAD Lung, a quantitative image texture analysis technology. 78'

[yump] 03/6/2020 13:55

I read all that a week or so ago and the takeaway is that non-invasive medical devices are, as far as I can make out, Class 1 and Class 1 devices do not need a Notified Body. Although the company might use one in its own right to make sure it is complying. But it doesn't need an official approval from the Notified Body.

Anyway it can't hurt to wave CE around, especially if it differentiates Bleepa.

[ged5] 03/6/2020 11:06

From post 5519

Need for notified body?

Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

In the Directive on Medical Devices, the medical device is classified in accordance with the provisions of Annex IX of the MDD as class I (low risk), class IIa or IIb (medium risk) or class III (high risk). The involvement of a Notified Body is not necessary for medical devices of class I unless they have a measuring function or are placed on the market in a sterile condition.

A Notified Body verifies in most of the cases only the quality management of the manufacturer. For all medical devices belonging to class III, and for medical devices belonging to class IIa and IIb on a representative basis, the design of the medical device and its compliance with the Essential Requirements must be examined by a Notified Body. The Notified Body issues a certificate that indicates, by referring to one of the Annexes II to VI of the MDD, what has been verified.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive, country or by the Notified Body's number (indicated next to the CE marking) via the NANDO homepage.
Check conformity

Subject to the class of the medical device, the manufacturer has different options as to how to assess the conformity of the medical device. The stringency of the conformity assessment procedures depends on the class of the medical device. For each class, the manufacturer has the choice between two or more conformity assessment procedures. Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II to VII of the MDD. In both cases, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues (a) certificate(s) that indicate(s), by referring to one of the Annexes, what has been verified.

Whether the involvement of a Notified Body has been necessary or not, the manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.
Technical documentation

Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.

The manufacturer or the authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of at least 5 years, in the case of implantable devices at least 15 years, after the last product has been placed on the market.





I've just noticed Meganxmas posted a link to the government site.

[ged5] 03/6/2020 10:52

I wouldn't get too uptight about the CE mark, Yump. I did put a link to the CE regulations in a previous post.

I don't think for one minute that anybody thinks the CE mark is the most essential part of Bleepa.

If Tom Oakley hadn't emphasised the CE mark we'd be all complaining about his naivety in underplaying the announcement.

I think he emphasised the extra selling point. Not just the only device with clinical grade imaging but also the only one that's been officially recognised as such.

[yump] 03/6/2020 07:49

In the end The lack if a CE mark would be an obstacle, so being able to mark Bleepa is essential - don’t want to stall at the end of a sales process with a question about meeting regs.

I just hope Tom Oakley doesn’t think its a door-opener. It will not be the first question a potential customer asks and its not the first thing you’d talk about.

Best case: he’s been told “come back when you’ve committed to meeting the regs by putting a CE mark on it and we’ll use it”.

[riggerbeautz] 02/6/2020 23:41

Happy birthday Ged, I recommend a lot to someone who seems interested, though at times, I can never quite make them out! Reading is good, it makes you think and as I’ve kind of said recently elsewhere, never ever stop learning; only a fool thinks he knows everything.

Anyway, still here with a stake. Glta.

Edit: b.t.w if you enjoy it, without looking, there’s usually a list of other books in the series; some well researched and concise versions in that little book series, there might be a few others you would find useful.

[ged5] 02/6/2020 22:58

It was also my second daughter's birthday yesterday. We had a Zoom party. Usually Thank you! It was my second daughter's birthday yesterday. It's usually one of the best weekends of the year.

At least two of my daughters visited today with some of my grandchildren. My son was also here. All social distancing.

I do miss tantrums and I must hide my laughing.

[lr2] 02/6/2020 22:46

Happy Birthday Ged. 'Twas my daughter's birthday yesterday. I might be able to remember yours next year with luck.

[ged5] 02/6/2020 22:31

Riggerbeautz,

I read on another thread that you recommended 'The little book of behavioral investing'. I mentioned the book to my beautiful wife some time ago.

It's my birthday today and lo and behold I received it today. I look forward to reading it!

Thank you!

Amazon? Microsoft?

[riggerbeautz] 02/6/2020 22:07

Keep glancing in here, nothing really to add other than decent little moves on CE Mark but it seems so well flagged in expectation that it’s nothing but confirmation really. So as a relative newcomer seems to me what would make the market sit right up, is somebody new partnering with Bleepa, hopefully the CE Mark is just a jigsaw piece towards that.

[meganxmas] 02/6/2020 22:02

Guidance on class 1 medical devices - GOV.UKhTtps://www.gov.uk/government/collections/guidance-on-class-1-medical-devices

[petekand] 02/6/2020 21:37

Surely it’s not just a case of slapping a CE mark without satisfying oneself that a product meets any requirements as you will open yourself up to litigation if it’s found to be deficient later on?
So, maybe it was prudent to let an independent third party such as Pennine to test it out first ensuring it also meets MDD standards.

[lr2] 02/6/2020 20:10

Last trade was a UT at 1.3p so technically the mid close was 1.3p as the UT indicates an agreed price between buyers and sellers but tomorrow it will start around 1.225p as the spread before the UT was 1.15p - 1.3p.

[ducatiman] 02/6/2020 20:04

Charts above registering a 1.3 mid close but my monitor not showing that!

[yump] 02/6/2020 19:38

Well the legal angle about other devices not having the CE mark and the general marketing directed at publicising the CE mark are very positive, given that a business would be liable for putting a CE mark on something that did not meet with the various requirements of its market.

However the idea that the Pennine trust can have any influence over the CE mark is wide of the mark. There are a collective set of EU H&S requirements. They cover the overall market. If you meet those you can mark up your products and if you cheat, then you're liable. Its up to the manufacturer or distributor to make sure the product meets the requirements of each market, for its CE mark.

The reporting is way off however.
This idea of receiving, being awarded or given a CE mark by a customer is just wrong.

I notice Proactive brown nosers have mis-reported it as well. Not that I expected them to report anything accurately or do any real research.

I just hope that the emphasis given by FDBK is a marketing ploy and not a misunderstanding.

All they needed to do was make sure they met the standards, document that they did and then stick their CE mark on the product. Possibly verified by an independent party, but unlikely as it is not an invasive medical device.

Oh yump, surely you don't know better than Tom Oakley ?

Well it depends on how you want to phrase your comments about CE marks, doesn't it ?

[ged5] 02/6/2020 14:55

More publicity!

[ged5] 02/6/2020 14:39

LR2, Post 5623. Three votes.

[meganxmas] 02/6/2020 13:54

No idea ... but opens on my mobile when click the link !?!?

[lr2] 02/6/2020 13:31

Great. Looks like Bleepa has two votes then.

[digger2779] 02/6/2020 13:29

LR2 - yup.

[lr2] 02/6/2020 13:05

Have you voted yet?

[lr2] 02/6/2020 11:41

Still not providing a clickable link Megan. No idea what is causing it but try the following if using a PC:

1. use touchpad to triple tap on page link to highlight
2. Ctrl + C to capture / copy the link
3. Ctrl + P to paste link in your next post.

Good luck.

[meganxmas] 02/6/2020 11:26

Https://twitter.com/BleepaMe/status/1267733489228689413?s=19