Whitepaper: Unleashing the Power of AI in Medical Devices

Recent advancements in Artificial Intelligence (AI) have impacted the evolution of medical device technology making it more precise, efficient and effective. This whitepaper explores the use of Artificial Intelligence as it is applied to medical device technology, discussing the benefits and challenges posed. Regulatory authorities recognise the need to provide guidance on safe development and maintenance of medical devices incorporating Artificial Intelligence to manufacturers. The whitepaper reviews the dynamic regulatory landscape for these products, where regulators are in the process of developing key principles, standards and guidance.

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Meet the Author

Indraj Bamrah, Principal Regulatory Consultant & MedTech Team Lead, DLRC Group

Indraj DLRC in 2021 and is responsible for leading the MedTech Consulting team at DLRC. Indraj has over 12 years of experience in Medical Device Regulatory Affairs and Quality Assurance having worked in industry and consulting roles. She has supported clients during all phases of development, having successfully achieved CE Certification and 510(k) clearance for a variety of devices across a wide range of therapeutic areas. Her expertise lies in strategic support, gap analysis, clinical evaluation, technical documentation creation, procedural support, device submissions and training.

Indraj has previously held positions at the MHRA, Stanmore Implants, Biomet and Emergo. Indraj has a MEng in Medical Engineering from Cardiff University.

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