Tips for Manufacturers Preparing for an FDA PMA Submission
Discover practical tips and key strategies to improve your FDA PMA submission.
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US Medical Device Market Entry: Key Strategies and Burdens
Responsible for approximately 50% of the estimated USD 578.75 billion global medical device market (in 2024), North America continues…
Key Global Markets for US Medical Device Manufacturers
For US medical device manufacturers considering non-US markets, understanding the influence of North America’s dominant medical device landscape and…
eSTAR Guidelines for Successful FDA Submissions
All medical devices seeking to market into the US may require multiple submissions of various types to the Food and…
Navigating Compliance with AI and Machine Learning in SaMD
The medical device industry continues to grow and evolve, becoming increasingly reliant on technology, making software a crucial component of…
ISO 13485 Medical Devices: Global Regulatory Compliance
ISO 13485:2016 standards play a fundamental role in global regulatory compliance for medical devices. Nearly 30 years after the initial…
EU MDR
EU IVDR
US Agent
General
UK Responsible Person
Egypt Registration Holder
Australian TGA Sponsor
QA Consulting
Swiss Authorized Representative
Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
FDA Human Factor in Medical Device Risk Management
Using any type of product in a manner not intended by its manufacturer has the potential to cause harm, a…
Predetermined Change Control Plans (PCCP) for Medical Devices
The FDA has recently issued a draft guidance for Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance,…
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