USA – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and...
Biologic and Biosimilar Misinformation: FDA Drafts Guidance

USA – FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances

Two new guidances using the US Food and Drug Administration’s (FDA) safety and performance-based pathway make it easier for less complex sutures and orthopedic...

USA – Commenters seek improvements in FDA’s computational modeling draft guidance

Stakeholders who commented on draft guidance from the US Food and Drug Administration (FDA) for assessing credibility of computational modeling and simulation (CM&S) generally...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – Brazil’s ANVISA issues registration rules for software as a medical device (SaMD)

ANVISA, Brazil’s medical device market regulator, has published new regulations targeting software as a medical device (SaMD) set to take effect in July 2022. ANVISA’s RDC...

USA – RF Quarterly, April 2022: Software as a medical device

In Software development Jaap Noordmans notes that the most important activity in software development is defining the requirements because architecture, risk management, and deliverables depend squarely on...

USA – Clinical evaluation of software

Software has become an increasingly critical area of healthcare product development. Rapid technological advancement has resulted in substantial changes to software function and acceptance,...

USA – MDUFA V: US FDA sets performance goals for De Novo medical device...

The US Food and Drug Administration (FDA) has issued a commitment letter describing draft amendments to its medical device review procedures. The agency is...

USA – Strengthening supply chains to mitigate medical device shortages

The US Food and Drug Administration (FDA) has issued a fact sheet aimed at educating stakeholders on how to prevent medical device shortages to protect public...

USA – Stakeholders ask for more time to transition EUA devices, diagnostics

Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular...
AMDR comments on issues of EU single-use medical devices specifications

USA – Digital human factors engineering platform now available for medical device manufacturers

Emergo by UL, a global medical device and healthcare technology consultancy, has launched a web-based platform, Optimal Product Usability Suite™ (OPUS). This software as...

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