Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be…
Posted on February 23, 2018 at 5:38am
A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.
The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several…Continue
Posted on February 20, 2018 at 5:02am
The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…
Posted on February 16, 2018 at 4:48am
Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.
Posted on February 14, 2018 at 5:03am