10 Best Practices for Post-Market Surveillance for SaMD
Post-market surveillance (PMS) for software as a medical device (SaMD) is a critical regulatory and operational requirement. It ensures ongoing safety, performance, and compliance once the product is launched in the market. SaMDs are reshaping modern healthcare. They...
Additive Manufacturing in Medical Device Industry: The Future
Additive manufacturing is revolutionizing the medical device manufacturing industry. It can be used to create complex, customized, and patient-specific products at unprecedented speed and precision. Additive manufacturing is opening new possibilities for medical...
How to Prepare for a Successful MDSAP Audit? Your Guide
Preparing for a successful medical device single audit program (MDSAP) audit requires strategic planning, robust documentation, and cross-functional alignment. For manufacturers seeking to demonstrate regulatory compliance across multiple jurisdictions, MDSAP is a...
An 8-Step Guide to Selecting a US FDA agent for Your Company
A U.S. FDA agent is a designated representative required for foreign companies that manufacture, process, or distribute FDA-regulated products. These products, such as medical devices, drugs, or food, should be intended for import into the United States. We have...