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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