Asphalion MedTech Blog
Introduction As medical device regulatory affairs professionals, we understand the critical role that post-market surveillance plays in ensuring medical devices’ safety and performance. One essential
Introduction In the highly regulated and competitive field of medical device development, implementing an effective Quality Management System (QMS) is not just beneficial; it’s essential.
Introduction As a medical device regulatory affairs professional, navigating the world of regulations can feel like maneuvering through a complex labyrinth. One of the first
Introduction In the highly regulated medical device industry, compliance with regulatory requirements is not just a legal demand but also a cornerstone of success and
Introduction The global medical device market presents a vast canvas of opportunity for manufacturers, but navigating the complex tapestry of diverse regulatory landscapes can be
Introduction In recent years, the field of medical device regulation has undergone significant changes, notably marked by the introduction of the Unique Device Identification (UDI)
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By Adi Ickowicz, BSc, ME
Senior Principal at the MedTech Unit of Asphalion S.L.
With over twenty-five years in the MedTech industry, Adi's extensive background includes leadership roles in regulatory affairs, clinical, and quality assurance departments across both well-established firms and start-ups. Additionally, he is a lecturer in various academic institutions.
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