A Guide to CE Mark For Medical Devices: What, How, & Why
To secure CE mark, the manufacturer is expected to ensure all EU-wide requirements for the medical device have been complied. If the device complies with strict safety, health, and environmental protection benchmarks, it may be granted the CE mark certification....
Dynamic Risk Management for Software-Enabled Medical Devices
An increasing number of software-enabled medical devices are being used in the healthcare industry. Manufacturers face unique challenges with the rise in use of software-enabled medical devices. Rapid design iterations, cybersecurity threats, integration of software...
Medical Device Packaging Shelf Life Testing and Validation
Medical device packaging aims to ensure sterility, safety, and effectiveness of the device from manufacture to the point of use. A tiered system of packaging is used for medical devices. The packaging level is defined by the proximity to the device. Primary...
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...