FDA defines data integrity as the completeness, consistency, and accuracy of data. Data Integrity is not a new concept and it has been a matter of concern since the paper and ink era. With the new computerized systems and cloud...
Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t...
On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. While the FDA is responsible for protecting public health by regulating drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does...
The Unique Device Identification system is used to identify the device throughout its distribution and use on the market. This system enables efficient post-market surveillance for medical device companies as well as for the FDA. FDA released a final guidance...
With the increasing use of software in every medical device, it is very important for every manufacturer to know how to correctly fit the software into their design control requirements outlined in 21CFR 820.30. If you have software as part of...
A root cause is a factor which caused a nonconformance and should be permanently eliminated through process improvement. Finding the root cause is done through root cause analysis which is a term describing a collective of approaches, tools, and techniques...
On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building upon the previous guidance, Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling, released in 2005. The draft guidance is expected...
Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in implementation of the device manufacturer's quality system. Any medical...
Does your Quality Management System support using a 3D printing process to manufacture a medical device or a component of a medical device? There are a few considerations when using 3D printing in the manufacturing process of a medical device. The...
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and...