As a Director of Medical Devices, Andromachi is responsible for defining and implementing regulatory strategies for the development and registration of innovative medical device/ HealthTech products as well as mentoring of early-stage start-ups. Through her role, she is determined to drive awareness of the changing medical device regulatory landscape using a variety of methods and channels. Her responsibilities also include activities supporting the successful certification against ISO 13485, MDSAP and MDR as well as assisting manufacturers to navigate the relevant regulatory requirements whilst ensuring they can remain agile.
Andromachi brings to the role more than 9 years of experience in the medical devices industry having worked with active device manufacturers of different regulatory maturity and product risk profile. During that time, she developed expertise in QMS development, implementation, certification and remediation in line with ISO 13485, 21 CFR 820, MDR and all MDSAP markets. She has also been instrumental in the transition of Technical Files from MDD to MDR, along with SaMD product up-classification. Having had several interactions with EU, UK and Canadian regulators as well as Notified Bodies on classification, certification and reporting matters, she is equipped with the experience required to anticipate the challenges that may arise and aims to ensure that strategies and roadmaps developed for medical devices take these into account. Finally, having worked extensively with software manufacturers, she is experienced with software development practices and how these could be adapted to meet regulatory requirements.
Andromachi began her career as a Research Assistant for a medical device laboratory, focusing on antennas for implantable and on/near-body wireless devices, where she experienced and better understood the challenges of designing innovative products as well as the considerations required to ensure successful transfer to manufacturing and subsequently to market. This understanding was further supported by subsequent roles that involved working with contract manufacturers and then bringing manufacturing in-house, whilst ensuring a smooth transition and successful site verification audit by the Notified Body.
Andromachi earned her Master of Science in Biomedical Engineering from Imperial College London, UK, and holds a Master of Engineering in Electrical and Computer Engineering from the National Technical University of Athens, Greece. Andromachi is based in London, UK.
Resources by Andromachi Kaltampani, M.Eng. M.Sc.
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Importance of Quality Management Review for Medical Devices
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Digital Health Series – Part 1: Defining Software as a Medical Device
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