Navigate Medical Device Approvals with the ASCA Program
A new program that FDA has authorized and kicked off is an accreditation program bringing to the medical device industry…
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Regulatory insights, industry news, and expert perspectives
Medical Device Pre-Market Cybersecurity: An Overview of Threat Modeling
As technology and computing become increasingly embedded throughout the life sciences industry, more and more medical devices rely on software…
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New Pre-market Submission Route: FDA’s eSTAR Program
Originally Published on January 12, 2023 by Sebastian Feye In September of 2018, the FDA took their first step to…
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Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development
Originally Published on April 22, 2021 by Sebastian Feye Acronyms: TPLC – Total Product Lifecycle AI/ML- Artificial Intelligence and Machine…
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An Overview of FDA Inspections across Drugs, Biologics and Medical Devices
Originally Published in November 18, 2020 by Sebastian Feye The Food and Drug Administration (FDA) primary responsibility is the enforcement…
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New Medical Device Pathway: Safety and Performance Based Pathway
Originally Published in August 31, 2020 by Sebastian Feye In late 2019, the FDA introduced a new Safety and Performance…
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Over-the-Counter (OTC) Drug Monographs Reform Summary
Published Originally in June 22, 2020 by Sebastian Feye Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing…
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Part 11 compliance is critical, Firms need to be aware of compliance with using the Cloud
Posted originally December 10, 2019 by Sebastian Feye 21 CFR Part 11 – Electronic Records Part 11 of the Code…
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PwC Risk Strategy and Emerging Technologies
Posted originally July 31, 2019 by Sebastian Feye Today I had the opportunity to listen into a PricewaterhouseCoopers (PwC) webinar…
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