Author: Nikita Angane

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...

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...

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...

As part of our blog series on Artificial Intelligence and Machine Learning Medical Devices, this time we will discuss the FDA’s take on how modifications made to the software after its initial review will be addressed within the SaMD pre-specifications and Algorithm Change Protocol submitted by the...

FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking great strides in establishing regulations for the digital health industry that also facilitates research and development while maintaining high quality products. In our...

With the initial Brexit plans derailed and the deadline now being extended to April 12th, the trade and manufacturing industry is in a state of chaos. The constantly changing regulations have put the stakeholders in a difficult situation. In preparation...

3D printing has a multitude of applications in the medical device field. Right from the inception of the additive manufacturing technique, engineers have been working on how this technology can serve the health care industry. Additive manufacturing has the capability...

Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. With all...