In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.
All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.
The Significance of Design Controls
In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.
Software as a Medical Device
Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….
Investigational Device Exemption
An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Concepts of Modern Quality systems
A quality system’s main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve…
How to Submit a 510K
Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.
Quality within an organization is everyone’s responsibility. From the highest-level executive to the intern who just...
The Failure Mode and Effects Analysis (FMEA) tool allows an organization to examine the possible hazards and risks...
Part of the design process is the development of what is known as Design Outputs. According to the FDA “Design Outputs...
The Role of User Needs in Design Controls
Engaging in medical device product development requires establishing and documenting design controls. The FDA requires...
The design and development process is long and challenging. At the end of the process comes what is known as...