ISO 13485 Certificate for Low-To-Moderate Risk Devices
The ISO 13485 guidelines provide a structured framework for establishing a quality management system that meets global standards. A properly designed and implemented QMS will ensure every step in the medical device production process is controlled and monitored. An...
12 Common Pitfalls in Medical Device Regulatory Submissions
We have discussed some of the common mistakes in medical device regulatory submissions. Understanding these common pitfalls will help streamline your application and improve your chance of approval. Additionally, we have provided some tips for avoiding these...
India Emerging as the Powerhouse in Global Medical Device Industry
India is slowly moving towards achieving its goal of becoming a global medical device industry powerhouse. Currently, India ranks among the top 20 medical device markets globally. More than 750 medical device manufacturers operate in India. With its robust...