Declaring Medical Device Equivalence: Key Criteria & Challenges
In this blog, we have provided an overview of what is medical device equivalence. Additionally, we have discussed the criteria and requirements that have to be fulfilled. Moreover, we have highlighted the common challenges encountered while trying to prove...
5 Tips for Conducting Effective Medical Device Market Research
Medical devices form the backbone of the healthcare sector. The diagnosis and prognosis of a disease or a medical condition depends on the effectiveness of the medical device. Hence, medical device entrepreneurs are constantly trying to tap into the potential of the...
SOPs for Medical Device Startup: 7 Key Medical Device SOPs
Medical device industry is highly regulated. Various documents are required to demonstrate regulatory compliance. Standard operating procedures (SOPs) are one such essential document required for medical device approval and market launch. SOPs outline the framework...
4 Key Steps for Effective Internal Audit of ISO 13485:2016 QMS
QMS helps ensure medical devices being manufactured are consistently meeting strict quality standards, thereby ensuring their safety and efficacy. A robust QMS helps medical device manufacturers reduce errors, minimize risks, and ensure product quality. The ISO...