#regulatory

I see clinicians as our end-users twice over: first, because they use the device in front of the...

I’ve spent the last decade-plus in quality at Class II medtech shops, and one thing that stays true...

To be fair, swapping a supplier or a component usually starts as a straightforward commercial ask:...

I used to think software was the easy bit: fewer moulds, no cleanroom, just code. Five years into MDR...

I stopped treating the usability file as a compliance artifact years ago — it’s where product design...

A tidy Design History File (DHF) isn't an audit prop; it's the single-document story of how your...

On July 10, 2026, the U.S. Cybersecurity and Infrastructure Security Agency (CISA) added two...

Genetic testing company 23andMe has agreed to an $18 million bankruptcy settlement with 43 U.S. states, including Pennsylvania, over a massive data breach discovered in October 2023. The breach, which impacted nearly 7 million customers, was attributed to credential stuffing attacks that succeeded due to poor security practices, such as a lack of mandatory multi-factor authentication (MFA). The settlement holds the company accountable for its security failures.

The U.S. Department of Defense (DOD) has suspended the Phase II implementation of its Cybersecurity Maturity Model Certification (CMMC) 2.0 program. This phase would have mandated third-party assessments for contractors handling Controlled Unclassified Information (CUI). While existing cybersecurity requirements under DFARS and NIST SP 800-171 remain in effect, the DOD is now soliciting industry feedback via a Request for Information (RFI) to reform the program.

Navigating MDSAP (Medical Device Single Audit Program) preparedness Requirements in...

The White House has officially launched 'Gold Eagle,' a new national cybersecurity initiative designed to serve as a central clearinghouse for software vulnerabilities. The program will leverage artificial intelligence to discover, prioritize, and coordinate the remediation of security flaws, particularly in open-source software and critical infrastructure. Managed by the Department of the Treasury, Gold Eagle brings together CISA, DHS, DoD, and private sector partners to accelerate cyber defense and reduce duplicative efforts.

Navigating Software as a Medical Device (SaMD) Architecture Requirements in Delhi NCR,...