Author: Dr Minu Lazar, BDS Designation: Clinical Evaluation Expert and Writer How do alternative and state-of-the-art devices contribute to demonstrating the safety and efficacy of a medical device In the European Union, medical devices are placed under severe regulation and enforcement to guarantee their safety and effectiveness. The European Medical Device Regulation (MDR) mandates that manufacturers…
Author: Dr Shrinidhi Ballal, MDS Designation: Clinical Evaluation Expert and Writer Proactive and Reactive Post Market Surveillance Activities: A Dual Approach to Device Safety According to the European Union Medical Device Regulation (EU MDR 2017/745) Post-market surveillance (PMS) are set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that…
High-quality medical equipment is a key determinant in the delivery of quality health care services in the healthcare industry. However, it is a big challenge to understand the different legal requirements for medical equipment, the purchase of equipment, as well as ensuring compliance in this field to various players such as healthcare institutions, manufacturers, and…
If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file the 510k application. If submitted too early, it can add to delays, more costs, or even recalls; submitted too late, it cannot be included in subsequent batches. At…
