MD&M East

Medical Device Software Development—Going Agile

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...
techUK

Event roundup: MHRA x techUK – introduction to software as a medical device (SaMD) regulation

In a member webinar hosted by techUK, experts from the Medicines and Healthcare products Regulatory Agency (MHRA) provided a comprehensive introduction to the UK’s regulatory framework for software as ...
MD&M East

Developing Safety-Conscious Software for Medical Devices

To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial. Timothy Cuff and Steven ...
FedTech Magazine

FDA Tightens Its Medical Device Cybersecurity Guidance

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
MobiHealthNews

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
The National Law Review

New UK Guidance on Software as a Medical Device

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
Digital Journal

Software as a medical device: Time to develop an ethical framework?

Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to roll out despite fears the ...
The National Law Review

Advocate General Opinion on Software Medical Devices

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
JD Supra

(Don’t Fear) the Regulator: FDA Clarifies When Software and Wellness Products Are Not Medical Devices

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...
Business Wire

Data From Propel Software Reveals Consumer Growing Reliance on Personal Medical Devices

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...