9-Step Guide to FDA Design and Development Planning
FDA design and development planning is a structured process mandated under 21 CFR Part 820 (Quality System Regulation). It serves as the mandated roadmap for controlling a medical device’s progression from initial concept to a validated product. It ensures...
6 Phases of Medical Device Development: Best Practices
Medical device development is a structured and highly regulated process. It takes a product from concept through design, testing, regulatory approval, and post-market monitoring to ensure safety, effectiveness, and compliance. It involves multiple phases, each with...
Design Control for Medical Devices: Key Elements & Importance
Design control for medical devices is a structured regulatory-mandated process. It ensures medical devices are designed to be safe, effective, and meet user needs before they reach the market. It is required under FDA’s 21 CFR, ISO 13485:2016, and indirectly under EU...
How to Register on CDSCO SUGAM Portal? Step-by-step Guide
The CDSCO SUGAM portal is India’s official online platform for regulatory submissions to the Central Drugs Standard Control Organization (CDSCO). It allows manufacturers, importers, and researchers to apply for approvals related to drugs, medical devices, cosmetics,...