MD&M East

A Complete Guide to Medical Device Design and Development

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
Forbes

User-Centered Research Methods For Medical Device Design

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
JD Supra

FDA Issues Guidance on AI for Medical Devices

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...