JD Supra

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
Control Global

Medical device control system cyber incidents have injured and killed people

The Federal Drug Administration’s current cybersecurity requirements are not appropriate for addressing and avoiding medical ...
JD Supra

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...
The National Law Review

FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

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 ...
Business Wire

Archimedic Launches OpenQMS, an Open-Access Quality Platform for Medical Device Development

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...
MD&M East

Traceability Requirements in EU MDR

In May 2021, Europe’s medical device regulation (EU MDR) will go into effect, replacing the existing medical device directive (MDD) that is currently in place. The impact of this regulatory change in ...
Plastics Today

Medical Thermoforming: Quality Control Best Practices

Customer requirements and regulatory classifications are driving increasingly rigorous quality control protocols in medical device thermoforming, with cleanroom manufacturing emerging as the gold ...
Business Wire

Medical Device Information Analysis and Sharing Initiative Welcomes Atrium Health

BEDFORD, Mass. & CHARLOTTE, N.C.--(BUSINESS WIRE)--MITRE, the independent trusted third party for the Medical Device Information Analysis and Sharing (MDIAS) Public Private Partnership (PPP), today ...
Medical Device and Diagnostic Industry (MD+DI)

Understanding the Dynamics in the Medical Device Industry in 2026

Trends for medical device manufacturers in 2026 include balancing sustainability costs, flexible automation, AI-driven ...

TEAM Technologies Rebrands as Cordica Medical

Cordica Medical serves medical device and pharmaceutical OEMs, with a growing specialty in advanced medical devices that are critical to the healthcare system. Through its comprehensive suite of ...
Pharmabiz

DoP calls for proposals to set up common facilities for medical device clusters

DoP calls for proposals to set up common facilities for medical device clusters: Gireesh Babu, New Delhi Monday, January 12, 2026, 08:00 Hrs [IST] The Department of Pharmaceutical ...