Asphalion MedTech Blog
Dive into the intricacies of the medical device regulatory landscape. Discover the importance of understanding varying global regulations, crafting a strong strategy, and the benefits of expert consultations. Whether you’re introducing a simple bandage or an advanced MRI machine, this blog guides you through the maze to achieve successful global market entry and ensure patient safety.
Aspects to be considered and practical tips for writing a compliant clinical evaluation report (CER)
More content coming soon…
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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