Ahead In The Cloud

1 min read

When Approved Supplier No Longer Means Controlled Risk

Most medical device manufacturers believe their supplier controls are stable. Suppliers are approved. Quality agreements are signed. Certifications...

3 min read

FDA to Modernize the 510(k) Program to Enhance the Safety and Effectiveness of Medical Devices

On November 26, 2018, the FDA announced changes to its 510(k) clearance pathway for medical devices. The statement from FDA Commissioner Scott...

2 min read

Blockbuster International Report Rocks Medical Device Industry

A nearly year-long international investigation into medical device safety by 252 journalists from 36 countries representing 59 media partners has...