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News and Insights
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 European Union Artificial Intelligence Act (EU AI Act) approved by the European Commission, is a pioneering regulatory framework...
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...
Accelerate Market Entry and Reduce Costs with 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...
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...
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