Head of Regulatory Affairs
1 MED
With a Master of Science in Biomedical Engineering, Alessandro Malaspina boasts over 10 years of professional experience specializing in medical device technology consulting.
In 2014, Alessandro joined 1MED SA: an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry
Alessandro coordinates the activities of the Regulatory Affairs team in 1MED, supporting the clients in the development of their medical devices, by tailoring the regulatory strategy and providing a thoughtful support through all the regulatory challenges.
Alessandro is also qualified as a lead auditor for the EN ISO 13485:2016 standard, with a long history of success in the implementation of MDR compliant Quality Management Systems and in the registration of medical devices in extra-CE Countries.
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Tuesday, May 7, 2024
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