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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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 of Federal Regulations applies to...
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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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