Following Brexit, UKCA marking has replaced CE marking for UK medical device regulations. This guide explores the latest MHRA compliance requirements, transition timelines, and how manufacturers can navigate Brexit medical regulations to maintain UK market access.

Clinical evaluation plays a critical role in both EU MDR clinical requirements and FDA medical device approval processes. This guide compares clinical study expectations, evidence requirements, and key regulatory pathways, helping manufacturers navigate approval processes efficiently.

Selecting the right Notified Body is essential for achieving CE marking under EU MDR compliance. With stricter regulatory approval processes, manufacturers must consider expertise, audit timelines, and industry recognition when making their Notified Body selection. This guide provides insights into choosing a trusted partner for market access.

Software as a Medical Device (SaMD) and AI in medical devices are transforming healthcare, but manufacturers must navigate complex SaMD regulation frameworks. This guide explores the latest regulatory compliance requirements for AI-driven medical technologies, covering EU MDR, FDA, and other international standards.

Medical device cybersecurity is now a priority, with the FDA cybersecurity guidance outlining stringent security requirements. This guide explores how manufacturers can design secure medical devices by implementing robust risk assessments, threat detection mechanisms, and compliance strategies to meet evolving regulatory expectations.

Complying with Unique Device Identification (UDI) regulations is mandatory for medical device manufacturers operating in the EU, US, and other markets. This guide breaks down UDI compliance requirements, including FDA UDI and EU MDR UDI standards, covering labelling, traceability, and data submission to ensure regulatory compliance.

Staying compliant with EU MDR regulations is essential for medical device manufacturers, as key EU MDR deadlines approach. Ensuring regulatory compliance involves updating technical documentation, implementing post-market surveillance (PMS) systems, and managing risk. This guide provides a roadmap to meeting compliance requirements while maintaining market access.

The FDA 510(k) submission process is a crucial step for securing medical device approval in the US. Many manufacturers struggle with delays due to incomplete applications or misunderstanding FDA regulatory requirements. This guide outlines best practices to streamline the submission process, avoid common pitfalls, and ensure full regulatory compliance.

Obtaining ISO 13485 certification is a fundamental requirement for medical device manufacturers to demonstrate regulatory compliance and ensure medical device quality. This guide explains the quality management system (QMS) requirements, how ISO 13485 aligns with global regulations, and strategies for achieving certification efficiently.

Post-market surveillance (PMS) is a critical aspect of EU MDR compliance, requiring manufacturers to monitor product performance, manage adverse event reporting, and submit Periodic Safety Update Reports (PSURs). This guide explains how to establish a robust medical device vigilance system to maintain market approval and meet regulatory compliance obligations.