The Asphalion MedTech Blog
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
Regulatory Affairs in Digital Health: Understanding the Changing Scene
Introduction In today’s rapidly evolving healthcare landscape, digital health technologies, including telemedicine and wearable devices, are big game changers. They’re making it easier to figure
Post-Market Clinical Follow-up (PMCF): A Crucial Component of Medical Device Evaluation
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
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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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