The Asphalion MedTech Blog
Overview of Premarket Notifications 510(k)
In the United States, medical devices are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 510(k) of this
Internal Audits: ISO 13485 conformity assessment
Elevate Medical Quality with ISO 13485 excellence
Regional Regulatory Challenges for Medical Device Market Access
Introduction The worldwide market for medical devices is growing, and with that growth, manufacturers face a complicated mix of rules and standards they must meet.
Medical Device Labelling and Packaging: A Guide for Regulatory Affairs Professionals
Introduction Medical device labelling and packaging play a crucial role in ensuring medical devices’ safety, performance, and efficacy. Properly designed and executed labelling and packaging
More content coming soon…
By Adi Ickowicz, BSc, ME
Over twenty-five years in the MedTech industry. His 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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