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FDA guidance updates, EU MDR developments, quality standards, and insights from Sequence Group consultants.
HIPAA applies to connected devices and SaMD only in specific situations. Learn when device data becomes PHI, how HIPAA d…
FDA Section 524B obligations don't end at clearance. This guide covers post-market SBOM monitoring, coordinated vulnerab…
FDA's eSTAR electronic template is now mandatory for 510(k) submissions. Learn how the guided format works, how it reduc…
Use-related risk is a leading cause of medical device recalls. This guide covers IEC 62366-1 and FDA human factors expec…
The FDA's QMSR became effective February 2, 2026, formally replacing the legacy QS Regulation and incorporating ISO 1348…
Four EUDAMED modules become mandatory on May 28, 2026. Manufacturers without a valid SRN cannot place devices on the EU …
On December 16, 2025, the European Commission proposed sweeping amendments to EU MDR and IVDR aimed at reducing administ…
UDI is now mandatory in the US, EU, and globally. This guide covers core requirements, implementation challenges, and mu…
Post-market surveillance is no longer passive. Both FDA and EU MDR require proactive, documented PMS systems that genera…
The FDA's finalized PCCP guidance allows manufacturers to implement planned algorithm modifications without a new market…
The FDA has finalized guidance on AI/ML SaMD, establishing a new framework for lifecycle management and predetermined ch…
The FDA issued a final rule establishing new regulations for the De Novo classification process for novel devices withou…
With EU MDR fully in effect and IVDR timelines advancing, manufacturers must understand the key differences from the leg…
Section 524B of the FD&C Act establishes mandatory cybersecurity documentation requirements for all connected medical de…
ISO 14971:2019 introduced important clarifications to risk management requirements. Understanding the differences from t…
Understanding the FDA's Refuse to Accept (RTA) policy is critical. This article covers the most common RTA failures and …
ISO 13485:2016 is the foundation of a compliant QMS. This guide covers key requirements, audit findings, and multi-marke…
A comprehensive guide to preparing your EU MDR 2017/745 submission.
Understanding the EU Medical Device Regulation 2017/745.
Step-by-step guidance on submitting a 510(k) De Novo request to the FDA.