Understanding the MDSAP Audit Cycle: A Comprehensive Guide
The Medical Device Single Audit Program (MDSAP) is one comprehensive audit for meeting the regulatory requirements of multiple participating countries. Achieving regulatory harmonization across different regulatory industries will help manufacturers easily launch...
IVD Technology Transfer in India: Key Components & Regulations
IVD technology transfer is crucial for manufacturers transitioning IVDs from development to full-scale production or relocating manufacturing between facilities. A successful transfer demands meticulous planning, comprehensive documentation, and alignment with...
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...