NEWS & INSIGHT

MDR/IVDR and EU AI Act: Is Your AI Medical Device at Risk of Non-Compliance?

The article summarizes the key regulatory domains, highlighting areas of alignment across MDR/IVDR and the AI Act (EU) 2024/1689, while also calling out the additional obligations that AI manufacturers must now implement without delay.

Using PCCP to reduce the number of FDA submissions for device changes

Predetermined Change Control Plan (PCCP) in FDA marketing submissions for AI-enabled medical devices, to avoid additional submissions.

EU AI Act's Impact On Medical Devices

The EU Artificial Intelligence Act approved by the European Commission, is a pioneering regulatory framework aimed at overseeing...

US FDA's 510(k) Review Process

The FDA’s 510(k) process is a key regulatory pathway for medical devices seeking market clearance in the United States, allowing...

Tailored Regulatory Strategy for US and EU Compliance

In today’s highly competitive global marketplace, the ability to bring new products to market swiftly and efficiently is a critical determinant of success. However, navigating the complex medical devices regulatory landscapes of different regions—especially the US and EU —can pose significant challenges for companies looking to expedite their time to market. A well-crafted regulatory strategy that is tailored to the specific requirements of these regions can not only speed up

FDA Breakthrough Devices Program

The FDA's Breakthrough Devices Program has a goal to provide timely access to innovative medical devices by speeding up review process.

In Vitro Diagnostic (IVD) Tests - US FDA and EU IVDR Regulation

Many diagnostic tests are commonly used for the clinical diagnosis of human diseases or conditions and in determining the state of...

Post Market Surveillance (PMS) under the EU MDR

The EU Medical Device Regulation (MDR, 2017/745/EU) came into force on May 25th, 2017. Legacy medical devices that comply with the...

FDA's Approch to Clinical Decision Support (CDS) Software

Many medical device companies are developing CDS tools to improve clinical practices and health outcomes. In this growing market, there...

Consulting with FDA under the Pre-Sub Process Before Submitting a 510(k)/ De Novo

Navigating the regulatory landscape for medical devices and in-vitro diagnostics (IVDs) can be a complex and challenging task. To...

Labeling requirements for medical devices

Regulatory labeling requirements for medical devices are constantly changing, presenting a challenge for manufacturers and distributors...