Asphalion MedTech Blog
Navigating the medical device regulatory maze
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.
Key Tips for Drafting a Compliant Clinical Evaluation Report (CER)
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.
Schedule a free meeting!
Discuss your case with our experts and receive a valuable feedback
