Up until recently, the government had legislated that medical emergencies in a muddy festival field, sports arena, or any other large-scale temporary...
This case study explores how Perci Health overcame this hurdle by partnering with 8foldGovernace. By providing expert support, we helped Perci ensure...
Healthcare is inherently a risk-averse environment. From delivering a baby to dispensing medication, risk permeates every aspect of day-to-day care. While the...
Key facts about Technical File Creation If you are developing a medical device, the "Technical File" (or “Technical Documentation” in some regulations)...
8foldGovernance launches training platform to meet growing demand for AI and Healthcare compliance knowledge 8foldGovernance has launched 8fold Training, a new digital...
Digital Health Technologies are facing increasing volatility from cyber threats. Earlier this month, global medtech manufacturer and NHS supplier Stryker reported a...
For years, NHS procurement operated on a foundation of credulity, allowing suppliers to navigate security requirements through simple self-certification. That era of...
Artificial intelligence is increasingly part of the conversation about very real pressures in the NHS, from workforce shortages to rising demand and...
This case study explores how Perci Health overcame this hurdle by partnering with 8foldGovernace. By providing expert support, we helped Perci ensure...
Digital technology has transformed mental healthcare, increasing accessibility, flexibility, and reducing stigma. However, this shift can create new barriers if manufacturers and...
In this guide, you’ll learn What the NHS DTAC means for enterprise healthtech companiesHow to streamline DTAC complianceReal-world enterprise success storiesThe benefits...
The Ultimate CQC FAQ: Everything Healthcare Providers Need to Know Care Quality Commission (CQC) compliance is crucial for many healthcare service providers....
Table of Contents Frequently Asked Questions Developed as the national baseline for compliance in the NHS, the Digital Technology Assessment Criteria or...
Introduction to NHS DTAC Version 2 (DTAC V2) The Digital Technology Assessment Criteria (DTAC) serves as England’s foundational framework for assessing digital...
For those needing to register with the Care Quality Commission (CQC), understanding the CQC registration process and its requirements before applying will...
With the increasing power and accessibility of AI systems, more and more medical devices and IVDs are integrating artificial intelligence. This could...
Digital health platforms are transforming how people access mental health support and manage their well-being. This includes not only dedicated mental health...
This case study illustrates how 8folds expert team supported Express Medicine to successfully register with the CQC, enabling them to conduct regulated...
ISO 27001 is an international standard, a document created by the International Organisation for Standardisation, which sets out best practices for creating...
Importance of ISO 27001 Compliance ISO 27001 is an international standard, a document created by the International Standards Organisation, which sets out...
Medical device regulators often rely on International Standards to guide medical device manufacturers and developers on how to meet their regulations; given...
Introduction Addressing the NHS Digital Technology Assessment Criteria can feel overwhelming, but it doesn’t have to be. As an enabling framework for...
Introduction Software as a Medical Device (SaMD) has become a crucial component of modern healthcare, providing innovative solutions for diagnosing, monitoring, and...
The NHS Data Security and Protection Toolkit (DSPT) is a vital compliance requirement for organisations managing identifiable data within the health and...
As political landscapes shift on both sides of the Atlantic, the future of Artificial Intelligence (AI) regulation is entering a transformative phase...
Introduction to IEC 62304 IEC 62304 is the international standard for software development and testing of medical device software that is well-recognised...
With healthcare innovation rapidly evolving and AI businesses leveraging vast amounts of confidential data, ISO 27001 stands as a foundation of information...
In an era of rapid digital transformation, healthcare technology plays a crucial role in improving patient outcomes and streamlining clinical operations. However,...
Understanding Regulators expectations for Medical Devices International Standards are the sources of best practice for Medical Device manufacturers to help ensure their...
At 8foldGovernance, we specialise in helping companies meet and exceed compliance expectations. With an in-house team of regulatory experts, we offer the...
There is a clear drive to digitise health and social care services; however, providers' digital transformation varies enormously. No matter where suppliers...
← Case Studies Supporting Collaboration How 8foldGovernance helped Smart Respiratory with 23 Integrated Care Boards through market-leading DTAC support CASE STUDY:...
Aligning quality management systems in healthcare. Quality management systems are commonplace in healthcare and all have similar fundamental elements. In the NHS,...
In the ever-evolving world of compliance, trust is paramount. Companies need partners who not only understand the complexities of regulations, but also...
In attempting to demonstrate compliance with CQC regulations providers can easily overlook several key elements. Exciting digital transformation initiatives often attract resources...
When healthcare innovators understand and can evidence compliance with international standards, the path to a successful DTAC is much simpler and cost...
AI Medical Devices (AiMD) and Software as Medical Devices (SaMD) manufacturers can speed up approvals and develop safer and more effective technology...
As product manufacturers and developers of health IT solutions respond to the technological opportunities of this digital healthcare revolution, they may have...
By Karen Whitton, Director of Clinical Risk, and Daniel Mannion, Head of Quality Assurance and Regulatory AffairsNavigating the intricacies of risk management...
Navigating the compliance pathway for healthcare products can be an uphill journey, especially when the path involves meeting the rigorous standards of...
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