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IF RNS is another 4,15 rns
would be an interesting finish to the afternoon
last
sales rns 29 th April
previous rns 30th March
if this afternoon or Monday will not surprise if rns
Wilson - thanks bud
The primary objective is to ensure medical devices consistently meet customer needs and applicable regulatory requirements while demonstrating a commitment to quality through continual improvement.
Testing, testing, testing - Novacyt.
Correction, - well done LoLo and Wilson!
Note the below transcript is incomplete, but the link enables access to document.
Well done LoLo
Wilson posted the link in his post at 03:03.
The article mentioned kits. There might be a confusion at a point between kits and tests. There might indeed refer to tests.
EM Analytical certified by LR in just 20 days.
26 May 2020
UK laboratory testing facility transforms business and secures ISO 9001 and ISO 13485 certification from Lloyd’s Register (LR) to manufacture COVID-19 testing kits.
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UK laboratory EM Analytical (EMA) has won a contract to manufacture millions of UK and WHO approved COVID-19 tests after securing certification to ISO 9001 (quality) and ISO 13485 (medical device) standards in just 20 days.
The contract with international diagnostics group, Novacyt, came at the right time. With serious cash flow issues after losing customers due to the pandemic, EMA needed a boost.
EMA Managing Director Daniel Royston said: “We had to win that work to save the business. We’re an interdisciplinary science lab providing equipment for universities, start-ups and SMEs R&D projects. New product development is just not happening for these organisations at the moment and we were very close to having serious financial issues if this was to go on for months on end.
“Once we were offered the contract, I took a £250K bank loan and re-mortgaged the house to pay for the additional instrumentation we needed. We repurposed the lab, making sure we could meet social distancing requirements. Using social media, I quadrupled the workforce in a week, recruiting lab technicians and diagnostics experts who had been made redundant or needed jobs and trained them online. We work to the rule ‘safety first, production second’ – everyone works in their own bay, they have full PPE and we have our team meetings in the field opposite for staff meetings!”
At the same time, Daniel contacted Lloyd’s Register (LR) to see if certification - a process which usually takes around three months – could be done within three weeks.
“LR said they could help – and they did. The medical team at LR were able to turnaround the contracts and design an initial audit plan in a very short timeframe. A lot of the audit was done remotely via Skype for Business. Sharing documents, video calls from home offices – it was certainly different, but it worked perfectly. Walk through video audits using a mobile phone meant the auditor could see evidence of our PAT testing, asset procedures and everything else they needed to complete the certification audit.
“The paper work requirements were immense. It was difficult – but nothing compared to setting up a lab in six days! Getting it over the line though is a huge credit to our team and LR. Without LR, we couldn’t have made the kits – and we couldn’t have helped save lives. It’s as simple as that.”
LR Medical Assessor Kenny McKeegan commented: “The primary objective of the ISO 13485 certification process is to ensure medical devices consistently meet customer needs and applicable regulatory requirements while ISO 9001 is all about demonstrating a commitment to quality through continual improvement.
https://www.lr.org/en-gb/latest-news/0526-em-analytical-certified-by-lr-
Prop5 I've posted it for him
I think I am right in saying there are 1540 TESTS in a KIT??
I wouldn't rule out monday for results .
Lolo - I’m reading your post..
The business has now scaled up operations to deliver 50,000 kits this week, 500,000 a week by the end of May and one million each week by the end of June !
You have put 50,000 KITS.. I take it the 500,000 a week by end of May is TESTS and not Kits??? (Although really hope it is kits!!)
I can’t see the article, Can anyone confirm?
Thanks for your help regarding the link Wilson. I thought it is interesting information to share hence my first post.
I hope we get a COVID sales status posted soon as it is the end of the month.
As the UK moves into the next phase, testing is critical to the success of the strategy. No let-up on that score. The hospital where my wife works has opened a second drive in bay, things are not easing up!
That is a great piece of research and another great example of what is going on behind the scenes. Just hope all this great information will finally find its way onto a superb RNS at some point to give us the much needed boost on the sp we need. Could be today but my guess in next week once the dust settles on what has been sold in May and what orders are in the pipe. Uk seems a different place but there are huge pockets in the world where testing at the moment is ultra critical. Let’s hope we have orders for these areas, to help us and the people who need it on the ground to save lives.
Thanks Lolo very interesting.
Now then EMA state from the end of June they can do 1 million Per week! for Novacyt.
https://www.reuters.com/article/brief-novacyt-sa-says-signed-manufacturi-idUSFWN2C313G
In the above article it states Novacyt are ramping up production to 8 mil(article mid April) over next three months, this I'm presuming was before ema and before talking to other manufacturers.
If my workings are correct Novacyt are going to have the capabilities to produce at least 12 mil a month by the end of June .
My last point regarding next day supply is this perhaps Ema's ramp up of manufacturing has been such that there are some additional supplies available to sell in the short term. All imho apologies for my delirious ramblings.
Wow - a ramp up worth having!
Reported 26 May, so 50,000 in previous week WE 22nd May perhaps, 500,000 in final week May.
Lolo think it's because you have only one post that the link was removed(seems to be the way) . Ceo is a "can do " type loan against house fair play to him and his wife.
Full nod to lolo for original research I will try and repost link.
https://www.lr.org/en-gb/latest-news/0526-em-analytical-certified-by-lr-in-just-20-days/
Great find and research. This is further concrete evidence there's a lot going on behind the scenes. Love some of the quotes by EMA managing director Daniel Royston: 'Instead I’m working all hours, seven days a week, and my wife is sticking labels on vials to help us while furloughed. But we’re playing our part in the fight against COVID-19 and that makes me extremely happy. I couldn’t let the business go under either – I had to save it, or at least know I’d done everything I possibly could. I am extremely proud of the team here, who are working just as hard'. And 'quadrupled the workforce in a week'. Novacyt are a great company producing a great product and supporting the industry.
https://www.lr.org/en/latest-news/ em-analytical-certified-lr-iso-9001-iso-13458/
The business has now scaled up operations to deliver 50,000 kits this week, 500,000 a week by the end of May and one million each week by the end of June !