DO YOU SUPPLY TO THE NHS ?
THEN YOU NEED PEPPOL
By September 30th 2018 all suppliers to the NHS must have PEPPOL as part of the new NHS eProcurement Strategy .
PEPPOL stands for Pan-European Public Procurement On-Line and is a network which allows suppliers and the NHS to share electronic business documents relating to e-commerce such as purchase orders and invoices , it allows electronic business documents to be easily and efficiently exchanged between the public sector and suppliers .
Any business that trades with the NHS must be part of the PEPPOL network by September . If you are not part of the PEPPOL network by September 30th 2018 – you will no longer be able to trade with the NHS .
Medilink North of England member , Kodit are PEPPOL experts and offers two options to get your business PEPPOL ready . Kodit can integrate PEPPOL into your existing ordering system or give you access to your own portal .
Kodit are happy to answer any questions you have regarding PEPPOL . For more information and to contact the Kodit team , visit www . kodit . com
MEDILINK MEMBERS UNITE TO REGULATE
Medilink members , MedBoardCo and Xiros have collaborated to create a platform which simplifies the new medical device regulation documentation and makes its navigation easier .
The Integrated Knowledge Platform uses digital formats , EU MDR 745 / 2017 and EU IVDR 746 / 2017 , alongside a search engine to highlight the relevant regulation information to the user .
Leeds based MedBoardCo recognised the difficulty medical device manufacturers face when trying to compute and integrate large regulation documents with additional requirements , implementing acts and technical information . To combat the complex regulatory problems medical device regulations manufacturers struggle with , they created a solution alongside fellow Leeds located company , Xiros .
Medilink member , Xiros aided MedBoardCo from concept design , to development and providing feedback - they were also one of the first companies to adopt the innovative technology . The Integrated Knowledge Platform displays all the associated regulatory information , correlations , GAP analysis , visuals and relevant external information applicable to the text .
The digital programme contains a comprehensive database with regulatory and technical information , which enables medical device manufacturers to access all important , legal documentation in one , easily searchable place .
Xiros ’ RA Manager , Kate Cole , said : “ For the Xiros regulatory team , it has been a particularly useful tool in planning our transition to meet the requirements of EU MDR 745 / 2017 and after transition we envisage it will remain a key regulatory resource for the team to ensure our continued compliance .“
PR SERVICES - MEET THE TEAM
INNOVATION FUNDING OPPORTUNITIES
Public innovation grants and funds can support the vital work of innovative organisations in the healthcare sector .
Here are some worthwhile opportunities that you might like to consider , brought to you by Medilink ’ s Innovation Team .
Biomedical Catalyst - Innovate UK
The aim of the Biomedical Catalyst is to support the development of innovative healthcare products , technologies and processes . Up to 70 % intervention depending on size of company .
Feasibility Award : Up to £ 200k Duration : 3-12 months Primer : £ 250k - £ 4m Duration : 12-24 months Early Stage : £ 240k - £ 4m Duration : 12 -36 months Late Stage : £ 200k - £ 4m Duration : 12 -36 months
Digital Health Technology Catalyst - Innovate UK
The aim of this competition is to address major healthcare challenges and grow the UK digital healthcare industry through the innovative use of digital technologies . Up to 70 % intervention depending on the size of the company .
Feasibility : £ 50k - £ 75k Duration : Up to one year Industry Research & Experimental Development : £ 500k - £ 1m Duration : Up to three years
Senior Innovation and Commercialisation Officer , Tom Wright , said : “ There ’ s never been more grant funding available to companies operating in the health sector than there is today .
“ Whether you are looking to support an existing project or investigate a totally new idea , grant funding is an excellent way to de-risk early stage work and accelerate your product development .”
For further information or support with your grant application contact our Innovation and Commercialisation team on innovation @ medilink . co . uk or call 0114 232 9292
SBRI Healthcare – NHS England
SBRI Healthcare is an NHS England initiative , led by the Academic Health Science Network ( AHSN ), who aim to promote UK economic growth whilst addressing unmet health needs and enhancing the take up of known best practice . 100 % intervention .
Phase 1 Feasibility : Up to £ 100,000 Duration : Six months Phase 2 Prototype Development : Up to £ 1m Duration : 12 months
Invention for Innovation ( i4i ) – NIHR
i4i advances healthcare technologies , devices and interventions for increased patient benefit in areas of existing or emerging clinical need .
I4i Connect : £ 50k - £ 150k Duration : 6-12 months and 100 % intervention
Product Development Award : No upper limit ( costs need to be justified ) Duration : Up to 3 years
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Jason Brannan BA ( Hons ) Chart . PR , Dip CIPR , MCIPR , MIoD is Medilink ’ s PR & Communications Director and has 17 years of direct experience in Business Strategy , Leadership , Business Growth , Public Relations and Communication working across the Healthcare Technology and Related Life Sciences Sector .
Jason has worked extensively with public and private sector bodies across Industry , the NHS and Academia , encompassing a local , regional , national and international remit .
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Our Senior PR Officer is Mary Hickey BA , PGDip , with over five years ’ experience working in PR in a variety of industries including local government , the third sector and higher education .
Mary works alongside the Director of Communications , by creating social media content and managing client ’ s social media channels , whilst also developing and delivering communication strategies .
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Medilink ’ s PR Assistant , Lizzie Day supports the team by creating member specific social media content to stimulate audience engagement and helps to produce the monthly E-News – a combination of member news and updates from across Yorkshire and Humber , the North East and the North West .
If you would like to speak to the PR team about enhancing your growth and connectivity ,
please email pr @ medilink . co . uk or call 0114 232 9292
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CLINICAL EVALUATION REPORTS
One area the new Medical Device Regulation ( MDR ) and In Vitro Diagnostic Regulation ( IVDR ) places greater emphasis on is the need for more self-generated clinical evidence in support of CE marked devices .
The Clinical Evaluation Report ( CER ) is a mandatory requirement for every medical device sold in Europe as stipulated in MEDDEV 2.7.1 Rev4 .
The same is true of the Performance Evaluation Report ( PER ) which is a mandatory requirement for every in
vitro diagnostic device sold in Europe , as stipulated in EU Reg 2017 / 746 . These documents analyse all clinical evidence you have gathered which support the claims and indications of the device , ultimately showing that the benefits of using the product outweigh any potential risks . These reports are a requirement for the Design History File .
Medilink are experienced authors of CERs for Class I , IIa , IIb and III medical devices and PERs for Class A , B , C and D in vitro diagnostic devices .
As well as writing the reports themselves , the Medilink team can also advise you on how to address gaps in your evidence to ensure continued compliance with the legislation .
For more information regarding your clinical evaluation needs , contact the Innovation and Commercialisation Team on innovation @ medilink . co . uk
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