SEQUENCE GROUP › NEWS & INSIGHTS
FDA guidance updates, EU MDR developments, quality standards, and insights from Sequence Group consultants.
IEC 62304 defines the lifecycle processes for medical device software, scaling rigor to safety Class A, B, or C. Learn t…
ISO 10993-1 is a risk-based biological evaluation process, not a fixed test checklist. Learn how device categorization, …
The Q-Submission Program lets you get written FDA feedback before you file. Learn what a Pre-Sub is, how to write strong…
Great Britain now runs its own medical device regime under the MHRA, separate from the EU. Learn how UKCA marking, MHRA …
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 Quality Management System Regulation (QMSR) became effective February 2, 2026, formally replacing the legacy Q…
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…
Unique Device Identification (UDI) is now mandatory in the US, EU, and a growing number of countries globally. This guid…
Post-market surveillance is no longer a passive activity. Both FDA and EU MDR require proactive, documented PMS systems …
The FDA's finalized guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled devices allows manufacturers t…
The FDA has finalized its guidance on Artificial Intelligence and Machine Learning-Based Software as a Medical Device (A…
The FDA issued a final rule establishing new regulations for the De Novo classification process — the pathway for novel …
With EU MDR fully in effect and IVDR timelines advancing, manufacturers must understand the key differences from the leg…
The FDA's final cybersecurity guidance establishes mandatory cybersecurity documentation requirements for all connected …
ISO 14971:2019 introduced important clarifications and changes to risk management requirements for medical devices. Unde…
Understanding the FDA's Refuse to Accept (RTA) policy is critical for 510(k) submitters. This article covers the most co…
ISO 13485:2016 is the foundation of a medical device quality management system. This guide covers the key requirements, …
A comprehensive guide to preparing your EU MDR 2017/745 submission, covering technical documentation, clinical evaluatio…
An overview of the EU Medical Device Regulation 2017/745 and its impact on medical device companies operating in the Eur…
A comprehensive guide to the FDA 510(k) De Novo pathway, including required submission elements, process navigation, and…