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 a new option for medical...
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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 and network communications to deliver...
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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 improve and modernize the process...
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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 learning SaMD – Software as...
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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 Based Pathway which can potentially...
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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 hosted by SDRAN discussing how...
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