On 29 June 2026, Switzerland issued a declaration under the Joint Statement on a Framework for a United States-Switzerland-Liechtenstein Agre...
FDA Updates Guidance on Exemptions for Certain Unclassified Medical Devices from Premarket Notification Requirements
The U.S. Food and Drug Administration (FDA) has issued an updated guidance document, “Intent to Exempt Certain Unclassified Medical Devic...
Navigating the New MDSAP Audit Approach (v.10)
The landscape of global medical device compliance officially shifted on February 2, 2026. With the U.S. FDA’s Quality Management System Regul...
UK MHRA Proposes Indefinite Recognition for CE-Marked Devices
The UK’s regulatory landscape for medical devices just took a major leap toward long-term certainty. On 16 February 2026, the MHRA released a...
The New Era of FDA Inspections
As of February 2, 2026, the landscape for medical device manufacturing has officially shifted. The FDA has fully implemented the Quality Manage...
RAPS 2025 – What We Learned About AI, Submissions, and Where Regulatory Heads Next
We are thankful for the opportunity to engage with a large number of attendees at the RAPS Convergence — especially our clients who stopped b...
FDA Quality Management System Regulation
The transition period for FDA’s Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820, will end on February 2, 2026, align...
