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Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Background In 2021, the U.S. Food and Drug Administration (FDA), Health…
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Overview Software (including AI) plays an essential part in health and…
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Guidance for care providers and local authorities on What Good Looks Like (WGLL) for digital working in adult social care.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
A guide for designated operators of essential services for healthcare in England explaining the practical impact of the NIS Regulations.
Guidance on the enforcement process for adult social care providers who do not comply with information requests under section 277A of the Health and Social Care Act 2012.
Guidance for adult social care providers to comply with information provisions under Section 277A of the Health and Social Care Act 2012.
Formal notice for adult social care providers, setting out the information required by the Secretary of State under section 277A of the Health and Social Care Act 2012.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
A guide to good practice for the use of digital technology in health and care.
Technical guidelines for healthcare professionals screening women at a higher risk of developing breast cancer.
This document sets out the NHS diabetic eye screening (DES) programme’s recommended cameras and settings for digital DES.
Funding to support local authorities in England in the dual running of the adult social care client level data (CLD) collection and Short and Long Term (SALT) return.
Technical specification and associated documents for individual care accounts, allowing local authorities to monitor a person's progress towards the lifetime cap on care costs.
Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.
Evidence-based principles for the effective use of screening appointment text message reminders in reducing inequalities and supporting informed choice.
Details and allocations of Department of Health and Social Care local authority-specific revenue funding for the financial year 2022 to 2023.
Information on purchasing, installing, maintaining and the quality assurance of breast ultrasound scanners for the NHS breast screening programme.
From discovery to real-world impact, VDEC equips scientists with the expertise and facilities to navigate each step in the development of vaccines and therapeutics.
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