Challenges Regarding MRA Update and their Impact Switzerland and the EU have made a Mutual Recognition Agreement (MRA) between themselves. Before implementing EU MDR, this MRA governed mutual access of medical devices to the Swiss markets. Also, before MDR’s implementation, the Swiss Medical Device Ordinance (MedDO, SR 812.213) adopted MDD, AIMD, and IVDR completely. This […]
The EUDAMED’s 1st module is becoming compulsory from December 2020. All medical devices’ manufacturers, authorized representatives, importers, and other important actors in the European market must register themselves and their roles in the system. The data is needed to be presented in the first module named as the Action Registration module. It is one of the […]
What is Bio-compatibility Evaluation? Biocompatibility evaluation is a process of determining a device’s compatibility with a biological system (in this case, of human beings). The purpose behind performing this test is to determine overall biological safety of a medical device for human use. Legacy Methods of Bio-compatibility Evaluation The legacy approach for biocompatibility evaluationi can […]
Field of medical and health sciences has been under a process of continuous evolution. Many new diseases and medical conditions arise daily, and so does their cure. Serious accidents which result in bone fracture are among one of the greatest threats medical science comes across. Sometimes, bones are damaged to an extent where their remodeling […]
A CER is a report based on in-depth analysis of clinical data which contains information regarding a medical device or an equivalent device. This report determines that whether the device was successful in achieving its intended purpose without posing risk for its users or not. EU MDR and CER CER is mandatory for all manufacturers […]
Manufacturing and selling of medical devices is one of the most crucial businesses in the world as the importance of producing life-saving equipment can’t be neglected. To minimize the risk of coming across with scandals such as PIP scandal, the EU has improved and upgraded its laws and regulations from MDD to MDR. The new […]
Millions of individuals around the world struggle with their health. Among those, many are admitted in the hospitals where they need support of different devices, machines and instruments which are produced by different manufacturers worldwide with great care. But sometimes, mishandlings happen which lead to various incidents. Different regulatory bodies around the world make sure […]
Starting a business and managing are two completely different tasks. While starting a business may not be as difficult as it seems, maintaining it and keeping it running smoothly surely demands focus and right decisions from its directors and company owners. A business will only be able to run smoothly if it can keep its […]
Organizing and running a medical devices business is a challenging task as compared to just getting up just as starter. It requires sufficiency and an efficient management to turn it into a successful one. Managing a business requires number of tasks to be done. They include planning of certain things, their accurate execution, and maintenance […]
Human Factor Engineering (HFE) is a field of science which revolves around obtaining of information regarding human physiological and psychological characteristics and their application on designing devices and systems for human use. New EU MDR The EU proposed a new set of regulations regarding medical devices. The requirements were supposed to be implemented from May […]
