8 Common Medical Device Biological Testing Methods
Medical device biological testing is a critical part of the regulatory approval process. In this blog, we have discussed the various medical device biological testing methods. Additionally, we have mentioned the parameters used to choose the appropriate test method...
IOL Cast Moulding Technology and Regulatory Guidelines
Intraocular lenses (IOLs) are tiny artificial lenses implanted inside the eye during cataract surgery. They are used to replace the natural lens that become cloudy as we age. In this blog, we will discuss why IOL cast moulding technology is becoming the gold...
5 Key Elements of an Effective CAPA System
An effective corrective and preventive action (CAPA) system is the backbone of a robust quality management system (QMS). It ensures that systemic issues are not only corrected but prevented from recurring. An effective CAPA system improves product quality and customer...
Role of Regulatory Affairs in the Medical Device Industry
The regulatory affairs team creates tailored regulatory strategies to ensure smooth market entry and compliance with international standards. They analyze product classification, applicable regulatory guidelines, and submission requirements. Moreover, they prepare and...