Clinical Investigation 101 for Medical Devices: Importance, Process, and Compliance with EU MDR
Clinical investigations are essential in the development and regulation of medical devices, ensuring their safety, efficacy, and performance. Under the European Medical Device Regulation (MDR) 2017/745, clinical investigations have become more structured and rigorous, requiring thorough planning, precise execution, and compliance with regulatory frameworks. In this blog, we’ll explore what clinical investigations entail, why they […]
Breaking Barriers in Women’s Health
Zara Malik, Head of Regulatory Affairs at LFH Regulatory had the privilege of attending the Innovation in Women’s Health webinar hosted by the Association of British HealthTech Industries (ABHI), and chaired by Women’s Health Ambassador, Dr Henrietta Hughes. The session brought together a vibrant group of #STEMinists — professionals united by a shared mission to […]
Custom Made Devices – How Are Custom-Made Medical Devices Regulated in the EU?
Are you a medical device manufacturer wondering how custom-made devices (CMDs) are regulated in the EU? Under Medical Devices Regulation (MDR) 2017/745, CMDs must comply with strict requirements to ensure safety and performance. This guide provides a clear breakdown of CMD compliance steps, key documentation requirements, and common challenges faced by manufacturers. The medical device […]
IEC 62304 Update: Powerful Changes You Need To Know And Why They Matter
Introduction to IEC 62304 IEC 62304 is a key international standard for the lifecycle processes of medical device software. It outlines the necessary processes for software development, maintenance, and risk management. Originally published in 2006, IEC 62304 has provided guidance to manufacturers, ensuring that software used in medical devices is safe, effective, and in compliance […]
This Is What You Need To Know About Regulatory Affairs In Change Management: Unlock Compliance And Dominate The Market
Introduction to Regulatory Affairs and Change Management Change is a constant in the medical device industry. From evolving regulations to technological advancements and shifts in product design, manufacturers must stay agile to thrive. Regulatory affairs play a critical role in managing these changes to ensure compliance with global standards, maintain product quality, and continue meeting […]
IEC 62366-12015 – Usability Testing for Medical Devices: What You Need To Know To Stay Compliant
Creating a usability file is essential in the product development process for medical devices, including Software as a Medical Device (SaMD), to ensure user-centred design and safety. IEC 62366-1 is the global standard outlining the process for usability testing in medical devices. This comprehensive guide will explore the critical steps involved in creating a usability […]