MEDIcept Insights
3 Reasons for Medical Device Consulting
Few industries evolve as rapidly as healthcare and medical device manufacturing. Digital transformation, healthcare reform, technological advances, and regulatory compliance issues can all significantly affect medical device design, manufacturing, and sales. It’s no...
Mock FDA inspections can help ensure regulatory compliance
Few industries are as heavily regulated as medical device manufacturing. Developing and producing a medical product is an expensive and time-consuming process even when everything goes smoothly. Things can quickly become even more expensive and challenging if your...
Think about package validation early in product development
Medical devices are often complicated and expensive machinery that must be treated with care. People’s lives may depend on these devices functioning properly, so why risk damaging the devices with shoddy packaging? Medical device testing is a rigorous and complex...
Health Canada Single Use Medical Device Commercial Reprocessing Requirements
Single use medical devices (SUD) are devices that are intended to be used only once and then disposed of.
IVD Genetic Testing Direct to Consumer (DTC) FDA Approval: Case Study
The area of genetic testing has expanded recently with more types of testing becoming available for both clinical and non-clinical applications.
Postmarket Management of Cybersecurity in Medical Devices
Many medical devices currently in commercial distribution today incorporate some type of software. Some devices use software to control certain aspects of the device or perform data analysis while others use it to connect to the Internet and health care provider networks for monitoring and sharing data.