Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Is FDA Getting More Cozy with AI?
FDA’s recent approval of stroke detection software paves the way for Artificial Intelligence applications to thrive on the healthcare landscape.
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Get Answers to Your Usability Testing Questions
A live demonstration of formative usability testing at MD&M East aims to share best practices and answer attendee questions.
New EU MDR Regulations and Revamp of the Medical Device Directive
An overview of the key impact points and challenges of European Union Medical Device Regulation.
Act Now to Prepare for MDSAP Audits
The clock is ticking for medical device manufacturers worldwide. Manufacturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the international Medical Device Single Audit Program (MDSAP) by now. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019. On that date, companies selling Class II, III, and IV medical devices and IVDs must have an MDSAP Certificate on file with Health Canada to maintain their Canadian Device Licenses.
FDA Exempts Over 1000 Devices from 510(k) Requirement
The 21st Century Cures Act paved the way for deregulation of a host of medical devices ranging from surgical lights to dentures.
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