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Exempt but not exempt
Compliance first time and ongoing audits
Why do Regulatory submissions fail?
SaMD right time for regulatory and quality involvement
e-QMS platform – When is the right time to have one?
Due Diligence for DTx and DDx
All about DHF
Documentation for Software Engineers at Medical Device Companies
The world of Software Medical Devices – Knowing the difference between SDP and SDLC
The world of Software Medical Devices – AI/ML challenges for compliance
Changes to Software at Medical Device companies
Home Use Devices
New devices to the market – 2 Greatest Challenges
New devices to the market – 2 most common problems
The Era of Digital Health – Software as a Medical Device (SaMD)
The Medical Device and IVD Industry – 5 Most Common Challenges
Why Elexes when many other regulatory firms exist?
About Elexes
The Era of Digital Health – KnowHow
Commitment – One most important thing in quality for Medical Devices
MDD to MDR transition – The Journey
Clinical Evaluation Report (CER)