HSA Draft Guidance on Clinical Evaluation: General Principles
The new article highlights the aspects related to the general principles of clinical evaluation.
The new article highlights the aspects related to the general principles of clinical evaluation.
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...
The new article highlights aspects related to changes to medical device registration and also describes in detail the public register of medical device manufacturers. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating...