Introduction
In the fast-evolving landscape of digital health, the need for credible regulatory partners has never been more crucial. Deviceology Ltd (“Deviceology”) is proud to share our recent collaboration with Anthropos Digital Care Ltd (“Anthropos”) to implement an ISO 13485 Quality Management System (QMS) and develop a Medical Device Product Technical File compliant with the UK Medical Devices Regulations (UK MDR), including adaptations post-Brexit, and the UK’s interpretation of MEDDEV 2.1/6.
This partnership has culminated in the successful registration of the Anthropos Falls Risk Engine (FRE) as a Class I medical device with the Medicines and Healthcare products Regulatory Agency (MHRA).
Project Overview
The Anthropos Falls Risk Engine (FRE) is designed to support the management of fall risk among the elderly and vulnerable populations. By leveraging 27 key health markers and a robust algorithm, the FRE analyses medical history, medication usage, and various physical measurements to assess an individual’s risk of falling.
This innovative tool is designed for use in both clinical and home settings, providing healthcare professionals and caregivers with valuable insights to facilitate early intervention and preventive healthcare measures.
Regulatory Journey
Creating a regulatory strategy is a critical step in bringing a medical device to market. Deviceology’s expertise in regulatory affairs has been instrumental in guiding Anthropos through this process. Our pragmatic approach ensured that the Anthropos FRE met all necessary regulatory requirements, culminating in its classification as a Class I medical device under UK MDR 2002.
The key stages of our regulatory journey included:
- Regulatory Background Review:
Understanding the UK MDR 2002 framework and its implications for the Anthropos Falls Insight Tool. - Device Determination:
Utilising the MHRA Device Determination Flowchart to establish that the FRE is a medical device. - Device Classification:
Assessing the device against relevant rules, confirming its classification as a Class I medical device. - Technical File Preparation:
Developing a detailed product technical file to support both Class I certification and potential future upgrades to Class IIa. - QMS Implementation:
Embedding an ISO 13485 aligned QMS within Anthropos, ensuring continuous adherence to high standards of quality and regulatory compliance. - MHRA Registration:
Successfully registering the Falls Risk Engine with the MHRA, allowing it to be legally marketed in the UK.
Importance of a Credible Regulatory Partner
In the highly regulated field of medical devices, having a reliable regulatory partner is essential. Deviceology’s role extended beyond mere compliance; we worked closely with Anthropos to understand their innovative vision and ensure that their groundbreaking tool could reach the market safely and effectively. Our partnership demonstrates the value of:
- Expert Guidance: Providing deep regulatory knowledge and experience to navigate complex compliance requirements.
- Comprehensive Support: Offering end-to-end support, from initial classification to post-market surveillance.
- Quality Assurance: Ensuring the highest standards of quality management through ISO 13485 QMS implementation.
When asked recently the Chief Technology Officer of Anthropos, Andy Van Heusen, comments that “ Deviceology have been instrumental in supporting Anthropos to accelerate our MHRA application. Their understanding of the process and procedures required and their ability to streamline these into our organisation has been flawless. Their knowledge of the intricate regulatory compliance and the changing landscape with alignment with Europe proved essential. They informed us at every step in the process and helped ensure our application is as future-proofed as possible for the upcoming changes in regulation.”.
Continuing the partnership
Anthropos is now planning a pilot for the Falls Risk Engine with Deviceology assisting in defining the Clinical Investigation Plan. This collaboration marks the beginning of a long-term partnership, with Deviceology committed to serving as Anthropos’ regulatory affairs partner for the foreseeable future as the device evolves and moves onto a higher risk class, preparing to enter other geographical markets including the EU and US.
Conclusion
Our journey with Anthropos underlines the critical role that credible regulatory partners play in the medical device industry. By combining our regulatory expertise with Anthropos’ innovative solutions, we are driving forward the future of digital health, ensuring that cutting-edge tools can make a meaningful impact on patient care.
Deviceology is proud to support innovators like Anthropos, and we look forward to continuing our mission of enabling safe, effective, and compliant medical devices in the market.
Stay Connected:
- Deviceology Website: www.deviceology.net
- Anthropos Website: Connected care for independent older living
- LinkedIn: Follow Deviceology on LinkedIn
For more information or to discuss how Deviceology can support your regulatory needs, contact us at info@deviceology.net.
