In this blog, we have curated a detailed step-by-step guide to help you avoid the common ISO 13485 audit mistakes. Additionally, we have highlighted why should you bother with ISO 13485 certification and how to secure it. What is ISO 13485? ISO 13485 provides...
Management review meetings or MRMs are vital for continuous improvement of the organisation and to achieve business excellence. Moreover, MRMs have a vital role in regulated environments, such as pharmaceutical, food, and medical devices industry. In this blog, we...
The Government of India has taken several steps to support the Indian medical devices industry. The government aims to make India the global manufacturing hub for high-quality and safe medical devices. Initiatives have been taken to boost foreign direct investments,...
The association of Indian medical device industry (AiMeD) is a platform for Indian medical device manufacturers and represents the Indian medical device industry. The platform acts as a single point of contact and provides various services to medical device...
Clean rooms are crucial for manufacturing industries where product quality is easily affected by factors, such as airborne particles. Thus, clean rooms are pivotal in a medical device manufacturing industry. Medical device quality affects the patient outcome. Hence,...