Robert van Boxtel @RobertMDProject
MDProject is an independent consultancy company active in the areas of medical devices, biotechnology and life science. mdproject.nl Netherlands Joined January 2011-
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@FHTperslucht Leg contact met bedrijven die momenteel beademingsapparatuur maakt. Bv Demcon, Drager, Ventinova. Zij kunnen vertellen wat je precies moet doen. Kijk ook op website MHRA voor specificaties en tips waar je bij ontwikkeling rekening mee moet houden.
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It appears that discussions between EU and UK are being continued in the public arena. How will this contribute to availability of food, work and healthcare accross EU and UK?
.@BorisJohnson, what’s at stake is not winning some stupid blame game. At stake is the future of Europe and the UK as well as the security and interests of our people. You don’t want a deal, you don’t want an extension, you don’t want to revoke, quo vadis?
@MedtechAmanda Indeed. But, when does the dust settle? Or are they still driving around creating new dust clouds?
@Invitrodiagnost @MedtechAmanda Ah, got it!
@Invitrodiagnost @MedtechAmanda Can you tweet the link, because the original link does not show any information still.
@Jan_vander_Kuil Qua product veiligheid ongeveer vergelijkbaar, echter, als duidelijk beschreven, beschikbaarheid wordt het probleem.
Robert van Boxtel retweeted
Cursusgids voorjaar 2019 additional training dates - mailchi.mp/804af371c1c4/c…
Impact of #Brexit on medical devices certified by BSI UK specific (and also relevant for those certified by other UK NB's. bsigroup.com/en-GB/medical-…
Robert van Boxtel retweeted
Op 23 mei is deze training wederom ingepland! Meld je nu aan voor die datum via [email protected] lnkd.in/gTASYSp lnkd.in/dRsPHPK
Robert van Boxtel retweeted
De MDR 5-daagse module training is wederom ingepland. Data: •Module 1 (26-03): Reason for changes, high level overview and impact transition period; Impact MDR on Manufacturers, Authorized Representatives, Importers and Distributors; Eudamed. •Module 2…lnkd.in/dh9vdfN
Brexit: Medical devices: UK MHRA: Legislation has been published which, in the event of the UK leaving the EU with no agreement, will cover the regulation of medicines, medical devices and clinical trials. lnkd.in/dgbWBWh lnkd.in/dhPRJqw
First NB has been designated under the EU MDR. BSI-UK. Interesting fact: will the EU accept their CE certificates after the Brexit? lnkd.in/g3Q42NU
Robert van Boxtel retweeted
Training "Validatie van QMS software o.b.v. GAMP 5" - Een praktische aanpak voor validatie van processoftware en tools, zoals vereist door ISO 13485:2016, op 7 februari 2019. Er zijn nog plaatsen beschikbaar! Zie voor meer details onze cursusbrochure op lnkd.in/dwjg6ic
The new EU MDR: Do not be afraid! Be ready! Join our MDR training Modules and get a discount when attending all five. Want to know more? Let me know and check our training brochure on the website mdproject.nl
Receiving PMS data on your medical devices directly from the hospitals? A selection of hospitals in NL is starting to facilitate this. Interested? Let me know!
French authority publishes information on absence of renewal of CE marking Allergan Breast Implants by Notified Body GMED. ansm.sante.fr/S-informer/Act…
Reactie IGJ op media storm #implantfiles igj.nl/actueel/nieuws…
Dutch TV journalists initiate worldwide investigation on safety on implants by International Consortium of Investigative Journalists. linkedin.com/feed/update/ur…
#EUMDR - new documents from EC available on MDR and IVDR. linkedin.com/feed/update/ur…
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