For those who may not be entirely familiar with the Medical Device Single Audit Program (MDSAP), this initiative is intended to allow auditors from MDSAP-recognized Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer’s quality...
Both the medical device industry and international regulators have witnessed the growing need for a standardized, worldwide approach to auditing and monitoring medical device manufacturing. A single, comprehensive process would reduce costs and speed time to market....
MEDDEV 2.7.1 and what it means for clinical evaluations and reports If you are a medical device manufacturer planning to sell your devices in Europe, you’re aware by now that there have been significant changes in EU regulations recently that affect how medical...
Here’s the dilemma that has faced US medical device manufacturers looking east to Europe for an easier path to increase sales: for years it has been easier to get medical devices to market in Europe….
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...
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...
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...
Single use medical devices (SUD) are devices that are intended to be used only once and then disposed of.
The area of genetic testing has expanded recently with more types of testing becoming available for both clinical and non-clinical applications.
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.