Essential Elements of a One-Page Regulatory and Compliance Strategy
Nobody writes a regulatory strategy that commits them to doing the bare minimum required by regulation to get a product to market and leave compliance activity to the last moment, but in practice this happens far too often. Unfortunately, a sad truth appears to be that when faced with competing pressures to bring a device to market, […]
International Recognition – Pathway to the UK
The MHRA recently released the following policy statement setting out a framework to allow devices with comparable regulator country (CRC) approvals access to the UK market depending on device type, class, and prior approval: (https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices) This welcome statement is an important step towards a smarter form of regulatory oversight for medical devices in Great Britain […]
UK –MHRA and DTAC update -March 2024
Deviceology took part in update meetings with NHS England and the MHRA in the last fortnight, outlining the direction of travel for revised UK medical device regulations and the NHS Digital Technology Assessment Criteria (DTAC). Our takeaways were: There will be significant alignment with the new UK MDR regulations and EU regulations when the scope […]
AI and the Evolution of Clinical Risk Safety Standards
AI-driven systems have the potential to significantly improve patient assessments, treatment pathways, and diagnosis accuracy. However, their integration into healthcare settings requires a new focus for clinical digital risks necessitating careful consideration and a new thinking to address the challenges DCB 0129 and DCB 0160 have been the cornerstone of clinical risk management in […]
Revolutionising Healthcare with AI Agents: Looking at OneAI and Beyond
The healthcare sector is undergoing a transformative shift with the advent of AI agents, championed by companies like OneAI. These AI/GPT-powered Agents are designed to revolutionise patient engagement, streamline healthcare management, and ensure the delivery of personalised care. With the integration of AI agents, healthcare providers can offer more accessible, efficient, and patient-centric services. OneAI stands out in the […]
Streamlining Medical Device Quality Compliance: The Transition from FDA QSR to QMSR
The U.S. Food and Drug Administration (FDA) have issued their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality management systems for medical devices. Therefore, the transition from the current Quality System Regulation (QSR, 21 CFR Part 820) to a new Quality Management System Regulation […]
Deviceology’s Expertise Unveiled: The Role of a Regulatory Affairs Consultant in Medical Device Market Entry
Bringing a medical device to market is an intricate and demanding endeavour. From the initial concept to product classification, and ultimately securing approval in your target market, these essential steps can pose significant challenges for both established entities and emerging enterprises in the medical device sector. Navigating the ever-changing landscape of medical device regulations adds […]
Unlocking Brazil’s Healthcare IT and MedTech Market Potential
1. Why Export to Brazil? As global leaders in Healthcare IT and Software as a Medical Device (SaMD), companies in the EU, US, and UK are strategically positioned to make a significant impact in the Brazilian market. Brazil, with its vast and growing healthcare sector, presents a lucrative opportunity for international medtech companies. This blog […]
The Regulation of Large Language Models & AI in Healthcare: The Promise and Peril
The rapid advancements in artificial intelligence (AI) have ushered in the era of sophisticated Large Language Models (LLMs), such as OpenAI’s GPT-4 and Google’s Bard. Notably, ChatGPT, GPT-4’s predecessor released in November 2022, garnered an astonishing 100 million users within two months of its launch, marking an unprecedented adoption rate for any emerging technology. This […]
NHS Mandate: Independent DSPT Audits Required for IT Suppliers
1. Introduction to NHS England’s New IT Supplier Category and Audit Requirements The NHS in England has introduced a vital categorisation known as “IT Supplier,” a significant recognition of external organisations that provide digital goods and services to the NHS or care organisations. This category is specifically designated for companies with over 50 employees and […]
