Get our free email newsletter

medical devices

EU Commission Updates Harmonized Standards for In Vitro Devices

The Commission of the European Union (EU) has updated its list of harmonized standards...

FDA Releases Guidance on UDI Systems for Medical Devices

The U.S. Food and Drug Administration (FDA) has published a Final Guidance on the...

FDA Issues Guidance on Remanufacturing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...

FDA Seeks Budget Increase, Especially for Medical Device Review

The U.S. Food and Drug Administration (FDA) is seeking an increase of over $550...

FDA Issues Guidance on Medical Device Safety in MRI Facilities

The U.S. Food and Drug Administration (FDA) has issued its final guidance on assessing...
- From Our Sponsors -

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...

FDA Releases 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

FDA Warns of Potential Effects of Magnets in Cell Phones and Smartwatches

The U.S. Food and Drug Administration (FDA) is advising consumers with embedded pacemakers and...

FDA Reverses HHS Action to Exempt Certain Medical Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has withdrawn a January proposal by the...

FDA Authorizes 50+ Testing Labs for Conformity Testing Pilot

The U.S. Food and Drug Administration (FDA) has now accredited more than 50 testing...
- From Our Sponsors -

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, and check out trending engineering news.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, and trending engineering news.